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1. Impact of the Coronavirus Disease 2019 Pandemic on Substance Use Disorder Risk Among People Living With Human Immunodeficiency Virus (HIV) Enrolled in HIV Care in the United States: An Interrupted Time Series Analysis

Author

Jain, Jennifer P, Heise, Megan J, Lisha, Nadra E, Moreira, Carlos H, Glidden, David V, Burkholder, Greer A, Crane, Heidi M, Jacobson, Jeffrey M, Cachay, Edward R, Mayer, Kenneth H, Napravnik, Sonia, Moore, Richard D, Dawson-Rose, Carol, Johnson, Mallory O, Christopoulos, Katerina A, Gandhi, Monica, and Spinelli, Matthew A

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Social Determinants of Health, Infectious Diseases, Drug Abuse (NIDA only), HIV/AIDS, Brain Disorders, Coronaviruses Disparities and At-Risk Populations, Emerging Infectious Diseases, Substance Misuse, Coronaviruses, Clinical Trials and Supportive Activities, Clinical Research, Sexually Transmitted Infections, Good Health and Well Being, COVID-19, depression symptoms, LGBTQ, substance use disorder, Clinical sciences, Medical microbiology
Abstract

BackgroundRising overdose deaths globally and increased social isolation during the coronavirus disease 2019 (COVID-19) pandemic may have disproportionately impacted people with human immunodeficiency virus (PWH) with substance use disorders (SUD). We examined trends in SUD risk among PWH before and after the COVID-19 shelter-in-place (SIP) mandate.MethodsData were collected between 2018 and 2022 among PWH enrolled across 8 US sites in the Centers for AIDS Research Network of Integrated Clinical Systems cohort. We evaluated changes in moderate/high SUD risk after SIP using interrupted time series analyses.ResultsThere were 7126 participants, including 21 741 SUD assessments. The median age was 51 (interquartile range, 39-58) years; 12% identified as Hispanic or Latino/Latina, 46% Black/African American, and 46% White. Moderate/high SUD risk increased continuously after the pandemic's onset, with 43% (95% confidence interval [CI], 40%-46%) endorsing moderate/high SUD risk post-SIP, compared to 24% (95% CI, 22%-26%) pre-SIP (P < .001). There were increases in the use of heroin, methamphetamine, and fentanyl, and decreases in prescription opioids and sedatives post-SIP. Further, there was a decrease in reported substance use treatment post-SIP compared to pre-SIP (P = .025).ConclusionsThe rising prevalence of SUD through late 2022 could be related to an increase in isolation and reduced access to substance use and HIV treatment caused by disruptions due to COVID-19. A renewed investment in integrated substance use treatment is vital to address the combined epidemics of substance use and HIV following the COVID-19 pandemic and to support resilience in the face of future disruptions.

Published
2024

2. Severity and Number of Substances Used are Independently Associated with Antiretroviral Therapy Adherence Over Time among People with HIV in the Current Treatment Era

Author

Ma, Jimmy, Delaney, Joseph A. C., Ruderman, Stephanie A., Nance, Robin M., Hahn, Andrew W., Drumright, Lydia N., Whitney, Bridget M., Fredericksen, Rob J., Mixson, L. Sarah, Merrill, Joseph O., Safren, Steven A., Mayer, Kenneth H., O’Cleirigh, Conall, Napravnik, Sonia, Chander, Geetanjali, Moore, Richard D., Christopoulos, Katerina A., Willig, Amanda L., Bamford, Laura, Webel, Allison, McCaul, Mary E., Cachay, Edward R., Jacobson, Jeffrey M., Saag, Michael S., Kitahata, Mari M., Crane, Heidi M., and Williams, Emily C.

Published
2024
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3. Biological and Clinical Implications of the Vascular Endothelial Growth Factor Coreceptor Neuropilin-1 in Human Immunodeficiency Virus

Author

Schnittman, Samuel R, Kolossváry, Márton, Beck-Engeser, Gabriele, Fitch, Kathleen V, Ambayec, Gabrielle C, Nance, Robin M, Zanni, Markella V, Diggs, Marissa, Chan, Fay, McCallum, Sara, Toribio, Mabel, Bamford, Laura, Fichtenbaum, Carl J, Eron, Joseph J, Jacobson, Jeffrey M, Mayer, Kenneth H, Malvestutto, Carlos, Bloomfield, Gerald S, Moore, Richard D, Umbleja, Triin, Saag, Michael S, Aberg, Judith A, Currier, Judith S, Delaney, Joseph AC, Martin, Jeffrey N, Lu, Michael T, Douglas, Pamela S, Ribaudo, Heather J, Crane, Heidi M, Hunt, Peter W, and Grinspoon, Steven K

Subjects
Biomedical and Clinical Sciences, Immunology, Heart Disease, HIV/AIDS, Infectious Diseases, Aging, Sexually Transmitted Infections, Heart Disease - Coronary Heart Disease, Prevention, Cardiovascular, 2.1 Biological and endogenous factors, Aetiology, Cancer, Good Health and Well Being, cancer, cardiovascular disease, HIV, neuropilin-1, VEGF, Clinical sciences, Medical microbiology
Abstract

Plasma vascular endothelial growth factor (VEGF) coreceptor neuropilin-1 (NRP-1) had the largest association with coronary plaque in the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) proteomics analysis. With little known about NRP-1 in people with human immunodeficiency virus (PWH), we explored its relation to other proteins in REPRIEVE and validated our findings through a Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) case-cohort study by assessing its relation to host factors and incident cardiovascular disease and cancer. Within REPRIEVE, NRP-1 was associated with proteins involved in angiogenesis, signal transduction, immunoregulation, and cell migration/adhesion. Within CNICS, NRP-1 was associated with key host factors, including older age and male sex. NRP-1 was associated with an increased hazard of multiple cancers but a decreased prostate cancer risk. Finally, NRP-1 was most strongly associated with mortality and type 2 myocardial infarction. These data suggest that NRP-1 is part of a clinically relevant immunoregulatory pathway related to multiple comorbidities in PWH. Clinical Trials Registration. NCT02344290.

Published
2023

6. Plasma Interleukin-6 (IL-6), Angiopoietin-2, and C-Reactive Protein Levels Predict Subsequent Type 1 Myocardial Infarction in Persons With Treated HIV Infection

Author

Graham, Susan M, Nance, Robin M, Chen, Junmei, Wurfel, Mark M, Hunt, Peter W, Heckbert, Susan R, Budoff, Matthew J, Moore, Richard D, Jacobson, Jeffrey M, Martin, Jeffrey N, Crane, Heidi M, López, José A, and Liles, W Conrad

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Atherosclerosis, HIV/AIDS, Infectious Diseases, Cardiovascular, Sexually Transmitted Infections, Heart Disease - Coronary Heart Disease, Aging, Heart Disease, Humans, HIV Infections, Interleukin-6, C-Reactive Protein, Cohort Studies, Angiopoietin-2, Case-Control Studies, Myocardial Infarction, Biomarkers, HIV infection, angiopoietin-2, C-reactive protein, interleukin-6, myocardial infarction, Clinical Sciences, Public Health and Health Services, Virology, Clinical sciences, Epidemiology, Public health
Abstract

BackgroundHIV infection leads to endothelial activation, promoting platelet adhesion, and accelerating atherosclerosis. Our goal was to determine whether biomarkers of endothelial activation and hemostasis/thrombosis were elevated in people with treated HIV (PWH) before myocardial infarction (MI).MethodsIn a case-control study nested within the CFAR Network of Integrated Clinical Systems (CNICS) cohort, we compared 69 adjudicated cases with type 1 MI with 138 controls matched for antiretroviral therapy regimen. We measured angiopoietin-1, angiopoietin-2 (ANG-2), intercellular adhesion molecule 1 (ICAM-1), vascular cell adhesion molecule 1 (VCAM-1), a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS13), von Willebrand factor, C-reactive protein (CRP), interleukin-6 (IL-6), plasminogen activation inhibitor-1, P-selectin, serum amyloid-A, soluble CD14, and apolipoprotein A1 in stored plasma. Conditional logistic regression identified associations with subsequent MI, with and without adjustment for Atherosclerotic Cardiovascular Disease (ASCVD) and Veterans Aging Cohort Study (VACS) scores.ResultsHigher IL-6 was associated with MI after adjustment for ASCVD score (adjusted odds ratio [AOR] 1.51, 95% confidence interval [95% CI]: 1.05 to 2.17 per standard-deviation-scaled log 2 increment). In a separate model adjusting for VACS score, higher ANG-2 (AOR 1.49, 95% CI: 1.04 to 2.14), higher CRP (AOR 1.45, 95% CI: 1.06 to 2.00), and higher IL-6 (AOR 1.68, 95% CI: 1.17 to 2.41) were associated with MI. In a sensitivity analysis excluding PWH with viral load ≥400 copies/mL, higher IL-6 remained associated with MI after adjustment for ASCVD score and after adjustment for VACS score.ConclusionsAmong PWH, higher levels of plasma IL-6, CRP, and ANG-2 predict subsequent type 1 MI, independent of conventional risk scores. IL-6 had the most consistent associations with type 1 MI, regardless of viral load suppression.

Published
2023

7. HIV post-treatment controllers have distinct immunological and virological features

Author

Etemad, Behzad, Sun, Xiaoming, Li, Yijia, Melberg, Meghan, Moisi, Daniela, Gottlieb, Rachel, Ahmed, Hayat, Aga, Evgenia, Bosch, Ronald J, Acosta, Edward P, Yuki, Yuko, Martin, Maureen P, Carrington, Mary, Gandhi, Rajesh T, Jacobson, Jeffrey M, Volberding, Paul, Connick, Elizabeth, Mitsuyasu, Ronald, Frank, Ian, Saag, Michael, Eron, Joseph J, Skiest, Daniel, Margolis, David M, Havlir, Diane, Schooley, Robert T, Lederman, Michael M, Yu, Xu G, and Li, Jonathan Z

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Immunology, Clinical Research, Sexually Transmitted Infections, Infectious Diseases, Genetics, HIV/AIDS, 2.1 Biological and endogenous factors, Infection, Good Health and Well Being, Humans, CD8-Positive T-Lymphocytes, Killer Cells, Natural, Lymphocyte Activation, RNA, HIV Infections, Viremia, HIV, analytical treatment interruption, post-treatment controller, reservoir, T cell
Abstract

HIV post-treatment controllers (PTCs) are rare individuals who maintain low levels of viremia after stopping antiretroviral therapy (ART). Understanding the mechanisms of HIV post-treatment control will inform development of strategies aiming at achieving HIV functional cure. In this study, we evaluated 22 PTCs from 8 AIDS Clinical Trials Group (ACTG) analytical treatment interruption (ATI) studies who maintained viral loads ≤400 copies/mL for ≥24 wk. There were no significant differences in demographics or frequency of protective and susceptible human leukocyte antigen (HLA) alleles between PTCs and post-treatment noncontrollers (NCs, n = 37). Unlike NCs, PTCs demonstrated a stable HIV reservoir measured by cell-associated RNA (CA-RNA) and intact proviral DNA assay (IPDA) during analytical treatment interruption (ATI). Immunologically, PTCs demonstrated significantly lower CD4+ and CD8+ T cell activation, lower CD4+ T cell exhaustion, and more robust Gag-specific CD4+ T cell responses and natural killer (NK) cell responses. Sparse partial least squares discriminant analysis (sPLS-DA) identified a set of features enriched in PTCs, including a higher CD4+ T cell% and CD4+/CD8+ ratio, more functional NK cells, and a lower CD4+ T cell exhaustion level. These results provide insights into the key viral reservoir features and immunological profiles for HIV PTCs and have implications for future studies evaluating interventions to achieve an HIV functional cure.

Published
2023

8. Transcriptomic Signatures of Human Immunodeficiency Virus Post-Treatment Control

Author

Wedrychowski, Adam, Martin, Holly Anne, Li, Yijia, Telwatte, Sushama, Kadiyala, Gayatri Nikhila, Melberg, Meghan, Etemad, Behzad, Connick, Elizabeth, Jacobson, Jeffrey M, Margolis, David M, Skiest, Daniel, Volberding, Paul, Hecht, Frederick, Deeks, Steven, Wong, Joseph K, Li, Jonathan Z, and Yukl, Steven A

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Immunology, Minority Health, HIV/AIDS, Health Disparities, Infectious Diseases, Sexually Transmitted Infections, Genetics, Infection, Good Health and Well Being, Humans, HIV Infections, HIV-1, Interferons, Interleukin-7, RNA, Viral, Transcriptome, Tumor Suppressor Protein p53, ART, HIV DNA, HIV posttreatment controllers, RNA splicing, analytic treatment interruption, cell-mediated immune response, human immunodeficiency virus, noncontrollers, splicing, transcription, transcriptional completion, transcriptional profile, treatment interruption, viremic suppression, Biological Sciences, Agricultural and Veterinary Sciences, Medical and Health Sciences, Virology, Agricultural, veterinary and food sciences, Biological sciences, Biomedical and clinical sciences
Abstract

Posttreatment controllers (PTCs) are rare HIV-infected individuals who can limit viral rebound after antiretroviral therapy interruption (ATI), but the mechanisms of this remain unclear. To investigate these mechanisms, we quantified various HIV RNA transcripts (via reverse transcription droplet digital PCR [RT-ddPCR]) and cellular transcriptomes (via RNA-seq) in blood cells from PTCs and noncontrollers (NCs) before and two time points after ATI. HIV transcription initiation did not significantly increase after ATI in PTCs or in NCs, whereas completed HIV transcripts increased at early ATI in both groups and multiply-spliced HIV transcripts increased only in NCs. Compared to NCs, PTCs showed lower levels of HIV DNA, more cell-associated HIV transcripts per total RNA at all times, no increase in multiply-spliced HIV RNA at early or late ATI, and a reduction in the ratio of completed/elongated HIV RNA after early ATI. NCs expressed higher levels of the IL-7 pathway before ATI and expressed higher levels of multiple cytokine, inflammation, HIV transcription, and cell death pathways after ATI. Compared to the baseline, the NCs upregulated interferon and cytokine (especially TNF) pathways during early and late ATI, whereas PTCs upregulated interferon and p53 pathways only at early ATI and downregulated gene translation during early and late ATI. In NCs, viral rebound after ATI is associated with increases in HIV transcriptional completion and splicing, rather than initiation. Differences in HIV and cellular transcription may contribute to posttreatment control, including an early limitation of spliced HIV RNA, a delayed reduction in completed HIV transcripts, and the differential expression of the IL-7, p53, and TNF pathways. IMPORTANCE The findings presented here provide new insights into how HIV and cellular gene expression change after stopping ART in both noncontrollers and posttreatment controllers. Posttreatment control is associated with an early ability to limit increases in multiply-spliced HIV RNA, a delayed (and presumably immune-mediated) ability to reverse an initial rise in processive/completed HIV transcripts, and multiple differences in cellular gene expression pathways. These differences may represent correlates or mechanisms of posttreatment control and may provide insight into the development and/or monitoring of therapeutic strategies that are aimed at a functional HIV cure.

Published
2023

9. Current Antiretroviral Treatment Among People With Human Immunodeficiency Virus in the United States: Findings from the Centers for AIDS Research Network of Integrated Clinic Systems Cohort

Author

Ma, Jimmy, Nance, Robin M, Delaney, Joseph AC, Whitney, Bridget M, Bamford, Laura, Gravett, Ronnie M, Moore, Richard D, Napravnik, Sonia, Mayer, Kenneth H, Jacobson, Jeffrey M, Christopoulos, Katerina, Burkholder, Greer A, Keruly, Jeanne, Eron, Joseph J, Martin, Jeffrey, Cachay, Edward R, Saag, Michael S, Crane, Heidi M, and Kitahata, Mari M

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Infectious Diseases, Sexually Transmitted Infections, HIV/AIDS, Infection, Good Health and Well Being, Acquired Immunodeficiency Syndrome, Alanine, Anti-HIV Agents, Anti-Retroviral Agents, Emtricitabine, HIV, HIV Infections, Heterocyclic Compounds, 3-Ring, Humans, Tenofovir, United States, ART utilization, ART treatment trends, ART guidelines, integrase inhibitor, tenofovir alafenamide, Biological Sciences, Medical and Health Sciences, Microbiology, Clinical sciences
Abstract

Among 14 049 people with human immunodeficiency virus in care in 2019-2020, 96% were treated with antiretroviral therapy (ART). Current antiretroviral treatment patterns highlight high uptake of guideline-recommended ART regimens including second-generation integrase strand transfer inhibitors (dolutegravir and bictegravir) and tenofovir alafenamide, especially in antiretroviral-naive individuals initiating ART.

Published
2022

11. The immunogenicity of an HIV-1 Gag conserved element DNA vaccine in people with HIV and receiving antiretroviral therapy

Author

Jacobson, Jeffrey M., Felber, Barbara K., Chen, Huichao, Pavlakis, George N., Mullins, James I., De Rosa, Stephen C., Kuritzkes, Daniel R., Tomaras, Georgia D., Kinslow, Jennifer, Bao, Yajing, Olefsky, Maxine, Rosati, Margherita, Bear, Jenifer, Heptinstall, Jack R., Zhang, Lu, Sawant, Sheetal, Hannaman, Drew, Laird, Gregory M., Cyktor, Joshua C., Heath, Sonya L., Collier, Ann C., Koletar, Susan L., Taiwo, Babafemi O., Tebas, Pablo, Wohl, David A., Belaunzaran-Zamudio, Pablo F., McElrath, M. Juliana, and Landay, Alan L.

Published
2024
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12. Discrimination and Calibration of the Veterans Aging Cohort Study Index 2.0 for Predicting Mortality Among People With Human Immunodeficiency Virus in North America

Author

McGinnis, Kathleen A, Justice, Amy C, Moore, Richard D, Silverberg, Michael J, Althoff, Keri N, Karris, Maile, Lima, Viviane D, Crane, Heidi M, Horberg, Michael A, Klein, Marina B, Gange, Stephen J, Gebo, Kelly A, Mayor, Angel, Tate, Janet P, Benson, Constance A, Bosch, Ronald J, Kirk, Gregory D, Marconi, Vincent, Colasanti, Jonathan, Mayer, Kenneth H, Grasso, Chris, Hogg, Robert S, Montaner, Julio SG, Sereda, Paul, Salters, Kate, Buchacz, Kate, Li, Jun, Jacobson, Jeffrey M, Thorne, Jennifer E, Brown, Todd, Tien, Phyllis, D’Souza, Gypsyamber, Smith, Graham, Loutfy, Mona, Gupta, Meenakshi, Rabkin, Charles, Kroch, Abigail, Burchell, Ann, Betts, Adrian, Lindsay, Joanne, Nijhawan, Ank, Mayor, Angel M, Gill, M John, Martin, Jeffrey N, Brooks, John T, Saag, Michael S, Mugavero, Michael J, Willig, James, Bamford, Laura, Eron, Joseph J, Napravnik, Sonia, Kitahata, Mari M, Sterling, Timothy R, Haas, David, Rebeiro, Peter, Turner, Megan, Lee, Jennifer S, McKaig, Rosemary G, Freeman, Aimee M, Van Rompaey, Stephen E, Morton, Liz, McReynolds, Justin, Lober, William B, Hogan, Brenna, You, Bin, Humes, Elizabeth, Gerace, Lucas, Stewart, Cameron, and Coburn, Sally

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Sexually Transmitted Infections, Aging, Infectious Diseases, Women's Health, HIV/AIDS, Aetiology, 2.4 Surveillance and distribution, Infection, Good Health and Well Being, Calibration, Cohort Studies, Female, HIV, HIV Infections, Humans, Male, Middle Aged, North America, Veterans, VACS Index 2.0, calibration, mortality, North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD)a of the International Epidemiologic Databases to Evaluate AIDS (IeDEA) and Veterans Aging Cohort Study, Biological Sciences, Medical and Health Sciences, Microbiology, Clinical sciences
Abstract

BackgroundThe updated Veterans Aging Cohort Study (VACS) Index 2.0 combines general and human immunodeficiency virus (HIV)-specific biomarkers to generate a continuous score that accurately discriminates risk of mortality in diverse cohorts of persons with HIV (PWH), but a score alone is difficult to interpret. Using data from the North American AIDS Cohort Collaboration (NA-ACCORD), we translate VACS Index 2.0 scores into validated probability estimates of mortality.MethodsBecause complete mortality ascertainment is essential for accurate calibration, we restricted analyses to cohorts with mortality from the National Death Index or equivalent sources. VACS Index 2.0 components were ascertained from October 1999 to April 2018. Mortality was observed up to March 2019. Calibration curves compared predicted (estimated by fitting a gamma model to the score) to observed mortality overall and within subgroups: cohort (VACS/NA-ACCORD subset), sex, age 500 copies/mL, CD4 count

Published
2022

13. 46. Racial and Ethnic Disparities in COVID-19 Incidence among Persons with HIV in a Multisite-Cohort

Author

Cachay, Edward R, Bamford, laura, Shapiro, Adrienne, Whitney, Bridget M, Wooten, Darcy, Karris, Maile, Smith, David, Bender Ignacio, Rachel A, Delaney, Joseph, robin, Nance, Keruly, Jeanne, Burkholder, Greer A, Napravnik, Sonia, Mayer, Kenneth, jacobson, Jeffrey M, Crane, Heidi, Kitahata, Mari, and Mathews, William C

Subjects
Clinical Research, Prevention, HIV/AIDS, Infectious Diseases, Infection, Good Health and Well Being
Abstract

Abstract: Background: Little is known about how race and ethnicity, imperfect (albeit accessible) proxies for structural racism, impact COVID-19 incidence among people with HIV (PWH). We report the cumulative incidence and incidence rate ratios (IRR) for COVID-19 in a long-term multi-site cohort of PWH across the US Figure 1. Cumulative incidence of COVID-19 in the CNICS cohort Methods: We examined COVID-19 cumulative incidence and IRR among PWH in care between 3/1/2020 and 12/31/2020 at seven sites in the CFAR Network of Integrated Clinical Systems (CNICS) cohort. We define COVID-19 incident case as having a laboratory-confirmed (RT-PCR/Ag) SARS-CoV-2 positive result or diagnosis verified by chart review. Reinfections were excluded. Results are presented as monthly and quarterly cumulative incidence and IRR with 95% CI stratified by CD4 count, self-reported race/ethnicity, and site. Follow-up was censored on the earliest of diagnosis of COVID-19 disease, loss to follow up, or 12/31/2020 Results: Among 15,780 PWH in care in the CNICS cohort during the study period, 62% were non-white, with a median (IQR) age of 52 (IQR 40-59), 95% were on antiretroviral therapy, 17% had a CD4 count less than 350, and 6% less than 200. Overall, 651 PWH tested positive for COVID-19 for a cumulative incidence of 4.13%. COVID-19 cumulative incidence increased from 0.77% at the end of the first quarter to 4.12% by the end of December 2020. At the peak of the pandemic in December 2020, the cumulative incidence in Black PWH was 1.68 fold higher than in white PWH (p=.033) and 2.35 fold higher in Hispanics than in whites (P< .0001), figure 1. Similarly, the IRR for COVID-19 was 1.71 (95% CI 1.42-2.07) for Black and 2.40 (95% CI 1.91-3.01) for Hispanic PWH relative to white. Although there was variation across sites, reflecting geographic differences in pandemic waves and access to COVID-19 testing, overall individual trends remained the same. COVID-19 cumulative incidence was similar across CD4 cell count strata Conclusion: Our results suggest effects of structural racial disparities on COVID-19 incidence in this diverse population of PWH across the US, with higher and disproportionate rates of COVID-19 in Black and Hispanic PWH. Incidence estimates are conservative because testing was not uniform, and no systematic testing was conducted Disclosures: Edward R. Cachay, MD, MAS, Gilead Science (Grant/Research Support, Advisor or Review Panel member)Merck Sharp & Dohme Corp (Grant/Research Support) Adrienne Shapiro, MD, PhD, Vir Biotechnology (Scientific Research Study Investigator) Darcy Wooten, MD, MS, Nothing to disclose Rachel A. Bender Ignacio, MD MPH, Abbvie (Individual(s) Involved: Self): Consultant; SeaGen (Individual(s) Involved: Self): Consultant Greer A. Burkholder, MD, MSPH, Eli Lilly (Grant/Research Support) Heidi Crane, MD, MPH, ViiV (Grant/Research Support)

Published
2021

14. Frequency of post treatment control varies by antiretroviral therapy restart and viral load criteria

Author

Fajnzylber, Jesse, Sharaf, Radwa, Hutchinson, John N, Aga, Evgenia, Bosch, Ronald J, Hartogensis, Wendy, Jacobson, Jeffrey M, Connick, Elizabeth, Volberding, Paul, Skiest, Daniel J, Margolis, David, Sneller, Michael C, Little, Susan J, Gulick, Roy M, Mellors, John W, Gandhi, Rajesh T, Schooley, Robert T, Henry, Keith, Tebas, Pablo, Deeks, Steve, Chun, Tae-Wook, Collier, Ann C, Hecht, Frederick M, and Li, Jonathan Z

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Sexually Transmitted Infections, HIV/AIDS, Clinical Research, Infectious Diseases, Clinical Trials and Supportive Activities, Infection, HIV Infections, Humans, Serologic Tests, Viral Load, CHAMP study team, Biological Sciences, Medical and Health Sciences, Psychology and Cognitive Sciences, Virology, Biomedical and clinical sciences, Health sciences
Abstract

Clinical trials including an analytical treatment interruption (ATI) are vital for evaluating the efficacy of novel strategies for HIV remissions. We briefly describe an interactive tool for predicting viral rebound timing in ATI trials and the impact of posttreatment controller (PTC) definitions on PTC frequency estimates. A 4-week viral load threshold of 1000 cps/ml provides both high specificity and sensitivity for PTC detection. PTC frequency varies greatly based on the definition of a PTC.

Published
2021

15. Risk of COVID-19 after natural infection or vaccination

Author

Adams, Atoya, Miller, Eric, Rankin, Bruce G., Shinn, Steven, Nash, Marshall, Green, Sinikka L., Jacobsen, Colleen, Krishnankutty, Jayasree, Phungwayo, Sikhongi, Glover, Richard M., II, Slechta, Stacy, Holdeman, Troy, Hartvickson, Robyn, Grant, Amber, Poling, Terry L., Klein, Terry D., Klein, Thomas C., Klein, Tracy R., Smith, William B., Gibson, Richard L., Winbigler, Jennifer, Parker, Elizabeth, Wijewardane, Priyantha N., Bravo, Eric, Thessing, Jeffrey, Maxwell, Michelle, Horn, Amanda, Healy, Catherine Mary, Akamine, Christine, Chu, Laurence, Chouteau, R. Michelle, Cotugno, Michael J., Bauer, George H., Jr., Hachigian, Greg, Oshita, Masaru, Cancilla, Michael, Kiersey, Kristen, Seger, William, Antwi, Mohammed, Green, Allison, Kim, Anthony, Desjardins, Michael, Johnson, Jennifer A., Sherman, Amy, Walsh, Stephen R., Borger, Judith, Saleem, Nafisa, Solis, Joel, Medina, Martha Carmen, Keating, Westly, Garcia, Edgar, Bueno, Cynthia, Segall, Nathan, Denham, Douglas S., Weiss, Thomas, Avworo, Ayoade, Hedges, Parke, Strout, Cynthia Becher, Santiago, Rica, Davis, Yvonne, Howenstine, Patty, Bondell, Alison, Marks, Kristin, Wang, Tina, Wilkin, Timothy, Vogler, Mary, Johnston, Carrie, Andrasik, Michele P., Andriesen, Jessica G., Broder, Gail, Eaton, Niles, Gelderblom, Huub G., McClennen, Rachael, Michael, Nelson, Robb, Merlin, Sopher, Carrie, Miller, Vicki E., Santiago, Fredric, Gomez, Blanca, Valika, Insiya, Starr, Amy, Cantos, Valeria D., Kandiah, Sheetal, Rio, Carlos del, Rouphael, Nadine, Edupuganti, Srilatha, Anderson, Evan J., Camacho-Gonzalez, Andres, Kamidani, Satoshi, Teherani, Meghan, Diemert, David J., Malkin, Elissa, Siegel, Marc, Roberts, Afsoon, Simon, Gary, Balani, Bindu, Stephenson, Carolene, Sperber, Steven, Cicogna, Cristina, Zervos, Marcus J., Kilgore, Paul, Ramesh, Mayur, Herc, Erica, Zenlea, Kate, Burgher, Abram, Milliken, Ann M., Davis, Joseph D., Levy, Brendan, Kelman, Sandra, Doust, Matthew W., Sample, Denise, Erickson, Sandra, Christensen, Shane G., Matich, Christopher, Longe, James, Witbeck, John, Peterson, James T., Clark, Alexander, Kelty, Gerald, Pena-Renteria, Issac, Koren, Michael J., Bartilucci, Darlene, Patel, Alpa, Tran, Carolyn, Kennelly, Christina, Brownlee, Robert, Coleman, Jacob, Webster, Hala, Fierro, Carlos A., Leistner, Natalia, Thompson, Amy, Gonzalez, Celia, Jackson, Lisa A., Suyehira, Janice, Haber, Milton, Regalado, Maria M., Procasky, Veronica, Lutat, Alisha, Griffin, Carl P., Hollister, Ripley R., Brown, Jeremy, Ronk, Melody, Harper, Wayne L., Cohen, Lisa, Eckert, Lynn, Hong, Matthew, Rouhbakhsh, Rambod, Danford, Elizabeth, Johnson, John, Calderone, Richard, Khetan, Shishir K., Olanrewaju, Oyebisi, Zhai, Nan, Nieves, Kimberly, O'Brien, Allison, Bradley, Paul S., Lilienthal, Amanda, Callis, Jim, Brosz, Adam B., Clement, Andrea, West, Whitney, Friesen, Luke, Cramer, Paul, Eder, Frank S., Little, Ryan, Engler, Victoria, Rattenbury-Shaw, Heather, Ensz, David J., Oplinger, Allie, Essink, Brandon J., Meyer, Jay, Raiser, Frederick, III, Mueller, Kimberly, Vrbicky, Keith W., Harper, Charles, Nutsch, Chelsie, Lewis, Wendell, III, Laflan, Cathy, Whatley, Jordan L., Harrell, Nicole, Shannon, Amie, Rowell, Crystal, Dedon, Christopher, Makhene, Mamodikoe, Gottschlich, Gregory M., Harden, Kate, Gottschlich, Melissa, Smith, Mary, Powell, Richard, Kimmel, Murray A., Pinto, Simmy, Vachris, Timothy P., Hutchens, Mark, Daniels, Stephen, Wells, Margaret, Van Der Leden, Mimi, Jackson-Booth, Peta-Gay, Baron, Mira, Kane, Pamela, Seversen, Shannen, Kryvicky, Mara, Lord, Julia, Saleh, Jamshid, Miles, Matthew, Lupercio, Rafael, McGettigan, John W., Jr., Patton, Walter, Brakema, Riemke, Choquette, Karin, McGettigan, Jonlyn, Kirstein, Judith L., Bernard, Marcia, Manning, Mary Beth, Rothenberg, Joan, Briskin, Toby, Roadman, Denise, Tedder-Edwards, Sharita, Schwartz, Howard I., Mederos, Surisday, Swaminathan, Shobha, Nyaku, Amesika, Varughese, Tilly, DallaPiazza, Michelle, Frey, Sharon E., Graham, Irene, Abate, Getahun, Hoft, Daniel, Allen, Leland N., III, Edwards, Leslie A., Davis, William S., Jr., Mena, Jessica M., Kutner, Mark E., Caso, Jorge, Moran, Maria Hernandez, Carvajal, Marianela, Mendez, Janet, Wadsworth, Larkin T., III, Adams, Michael R., Iverson, Leslie, Newberg, Joseph L., Pearlman, Laura, Nugent, Paul J., Reynolds, Michele D., Bashour, Jennifer, Schmidt, Robert, Sheth, Neil P., Steil, Kenneth, Toma, Ramy J., Kirby, William, Folmar, Pink, Williams, Samantha, Pickrell, Paul, Mott, Stefanie, Linebarger, Carol Ann, Malbari, Hussain, Pampe, David, Fragoso, Veronica G., Holloway, Lisa, McKeown-Bragas, Cecilia, Becker, Teresa, Williams, Barton G., Jones, William H., Clark, Jesse L., Shoptaw, Steven, Vertucci, Michele, Hernandez, Will, Spector, Stephen A., Moodley, Amaran, Blumenthal, Jill, Stangl, Lisa, Deutsch, Karen, Mullane, Kathleen M., Pitrak, David, Nuss, Cheryl, Pi, Judy, Fichtenbaum, Carl, Powers-Fletcher, Margaret, Saemann, Michelle, Kohrs, Sharon, Campbell, Thomas B., Lauria, Andrew, Mancilla, Jose C., Dunlevy, Hillary, Novak, Richard M., Wendrow, Andrea, Borgetti, Scott, Ladner, Ben, Chrisley, Lisa, Young, Cheryl, Doblecki-Lewis, Susanne, Alcaide, Maria L., Gonzales-Zamora, Jose, Morris, Stephen, Wohl, David, Eron, Joseph, Jr., Frank, Ian, Dunbar, Debora, Metzger, David, Momplaisir, Florence, Martin, Judith, Hoberman, Alejandro, Shope, Timothy, Muniz, Gysella, Rupp, Richard, Stanford, Amber, Berman, Megan, Porterfield, Laura, Lewis, Michael, Ghadishah, Elham, Yusin, Joseph, Pham, Mai, Creech, Clarence B., II, Walker, Shannon, Rolsma, Stephanie, Samuels, Robert, Thomsen, Isaac, Kalams, Spyros A., Wilson, Greg, Lucksinger, Gregg H., Parks, Kevin, Israelsen, Ryan, Ostovar, Jaleh, Kelly, Kary, Overcash, Jeffrey S., Chu, Hanh, Lee, Kia, De La Cruz, Luis I., Clemons, Steve, Everette, Elizabeth, Studdard, Suzanna, Mohan, Gowdhami, Tyson, Stefanie, Peay, Alyssa-Kay, Johnson, Danyel, Feldman, Gregory J., Suen, May-Yin, Muenzner, Jacqueline, Boscia, Joseph, Siddiqui, Farhan, Sanders, John, Peacock, James, Nasim, Julio, Levin, Michael L., Hussey, Julie, Kulic, Marcy, McKenzie, Mark M., Deese, Teresa, Osmundsen, Erica, Sweet, Christy, Ebuh, Valentine M., Elnagar, Elwaleed, Ebuh, Georgette, Iwuala, Genevieve, Han-Conrad, Laurie J., Simmons, Todd, Tarakjian, Denis, Ackermann, Jeremy, Adams, Mark S., Alemán, José O., Al-Ibrahim, Mohamed S., Andes, David R., Andrews, Jeb, Arduino, Roberto C., Bäcker, Martín, Badillo, Diana, Bainbridge, Emma, Batteiger, Teresa A., Bazan, Jose A., Bedimo, Roger J., Benitez, 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Grossberg, Robert M., Guanira-Carranza, Juan V., Guerreros Benavides, Alfredo Gilberto, Guillory, Clint C., Gunaratne, Shauna H., Halpert, David, Hamilton, Holli, Hartman, William R., Henderson, Sheryl L., Herati, Ramin, Guarin, Laura Hernandez, Hilder, Robin, Ho, Ken, Hojat, Leila, Hosek, Sybil G., Jacobson, Jeffrey M., Jay, Melanie, Johnson, Diane H., Jones, Kathleen S., Jones-López, Edward C., Justman, Jessica E., Kahney, Scott, Katz, Lois, Katz, Melinda, Kaul, Daniel, Keefer, Michael C., Kennedy, Ashley, Knishinsky, Jennifer, Kogelman, Laura, Koletar, Susan L., Kottkamp, Angelica, Laguio-Vila, Maryrose, Landovitz, Raphael J., Lee, Jessica L., Liu, Albert, Llerena Zegarra, Eneyda Giuvanela, Lok, Anna S., Lovell, James, Lubelchek, Ronald, Lucaj, John, Luckasen, Gary, Luetkemeyer, Annie, Lugogo, Njira Lucia, Maenza, Janine, Malvestutto, Carlos, Mauri, Monica, Maves, Ryan C., Mayer, Kenneth H., McCartney, Michael J., McCort, Margaret E., McElrath, M. Juliana, McNairy, Meredith, Merino, Fernando L., Meyerowitz, Eric A., Mitchell, Carol L., Monaco, Cynthia L., Muhammad, Sauda, Muñoz-Gómez, Sigridh, Munsiff, Sonal, Nee, Paul, Nollen, Nicole L., Noor, Asif, Lagos, Claudio Nuñez, Okulicz, Jason F., Oliver, Patrick A., Ortega, Jessica, Palmer, Steven, Parameswaran, Lalitha, Parikh, Purvi, Parker, Susan, Parungao, Reza, Pavie, Juana R., Madan, Rebecca P., Peralta, Henry, Petts, Jennifer, Pierce, Kristen K., Pretell Alva, E. Javier, Purpura, Lawrence J., Raabe, Vanessa, Recuenco, Sergio E., Richards, Tamara, Riddler, Sharon A., Rizzardi, Barbara, Rokser, Rachel, Rolle, Charlotte-Paige, Rosen, Adam, Rosen, Jeffrey, Freese, Lena R., Santolaya, María E., Schipani, Linda M., Schwartz, Adam, Schwasinger-Schmidt, Tiffany, Scott, Hyman, Sha, Beverly E., Shankaran, Shivanjali, Shapiro, Adrienne E., Sharp, Stephan C., Shopsin, Bo, Sims, Matthew D., Skipper, Stephanie, Smith, Derek M., Smith, Michael J., Sobhanie, M. Mahdee, Sovic, Brit, Sterling, Stephanie, Striker, Robert, Tafur Bances, Karla Beatriz, Talaat, Kawsar R., Tavel, Edward M., Jr., Tieu, Hong V., Tomaszewski, Christian, Tomlinson, Ryan, Torres, Juan P., Torres, Julian A., Treanor, John J., Tukuru, Sade, Ulrich, Robert J., Utz, Gregory C., Viar, Veronica, Viau Colindres, Roberto A., Walsh, Edward E., Walsh, Mary C., Walter, Emmanuel B., Weidler, Jessica L., Wu, Yi H., Yang, Kinara S., Yrivarren Giorza, Juan Luis, Zemanek, Arthur L., Zhang, Kevin, Zingman, Barry S., Gorman, Richard, Paez, Carmen A., Swann, Edith, Takuva, Simbarashe G., Greninger, Alex, Roychoudhury, Pavitra, Coombs, Robert W., Jerome, Keith R., Castellino, Flora, Tong, Xiaomi, Pavetto, Corrina, Gipson, Teletha, Tong, Tina, Lee, Marina, Zhou, James, Fay, Michael, McQuarrie, Kelly, Nnadi, Chimeremma, Sogbetun, Obiageli, Ahmad, Nina, De Proost, Ian, Hoseyni, Cyrus, Coplan, Paul, Khan, Najat, Ronco, Peter, Furey, Dawn, Meck, Jodi, Vingerhoets, Johan, Brandenburg, Boerries, Custers, Jerome, Hendriks, Jenny, Juraszek, Jarek, Marit de Groot, Anne, Van Roey, Griet, Heerwegh, Dirk, Van Dromme, Ilse, Méndez Galván, Jorge F., Carrascal, Monica B., Duran, Adriana Sordo, Sanchez Guerrero, Laura Ruy, Gómora Madrid, Martha Cecilia, Barrat Hernández, Alejandro Quintín, Guizar, Sharzhaad Molina, González Estrada, Denisse Alejandra, Martínez Pérez, Silvano Omar, Zárate Hinojosa, Zindy Yazmín, Ruiz-Palacios, Guillermo Miguel, Cruz-Valdez, Aurelio, Pacheco-Flores, Janeth, Lara, Anyela, Díaz-Miralrio, Secia, Reyes Fentanes, María José, Olmos Vega, Jocelyn Zuleica, Méndez, Daniela Pineda, Martínez, Karina Cano, Alvarez León, Winniberg Stephany, Ruiz Herrera, Vida Veronica, Vázquez Saldaña, Eduardo Gabriel, Camacho Choza, Laura Julia, Vega Orozco, Karen Sofia, Ortega Domínguez, Sandra Janeth, Chacón, Jorge A., Rivera, Juan J., Cutz, Erika A., Ortegón, Maricruz E., Rivera, María I., Browder, David, Burch, Cortney, Moye, Terri, Bondy, Paul, Browder, Lesley, Manning, Rickey D., Hurst, James W., Sturgeon, Rodney E., Wakefield, Paul H., Kirby, John A., Andersen, James, Fearon, Szheckera, Negron, Rosa, Medina, Amy, Hill, John M., Rajasekhar, Vivek, Williams, Hayes, Cade, LaShondra, Fouts, Rhodna, Moya, Connie, Anderson, Corey G., Devine, Naomi, Ramsey, James, Perez, Ashley, Tatelbaum, David, Jacobs, Michael, Menasche, Kathleen, Mirkil, Vincent, Winkle, Peter J., Haggag, Amina Z., Haynes, Michelle, Villegas, Marysol, Raja, Sabina, Riesenberg, Robert, Plavin, Stanford, Lerman, Mark, Woodside, Leana, Johnson, Maria, Healy, C. Mary, Whitaker, Jennifer A., Keitel, Wendy A., Atmar, Robert L., Horwith, Gary, Mason, Robin, Johnson, Lisa, Dora, Tambra, Murray, Deborah, Ledbetter, Logan, Ewing, Beverly, Stephenson, Kathryn E., Tan, Chen S., Zash, Rebecca, Ansel, Jessica L., Jaegle, Kate, Guiney, Caitlin J., Henderson, Jeffrey A., O'Leary, Marcia, Enright, Kendra, Kessler, Jill, Ducheneaux, Pete, Inniss, Asha, Brandon, Donald M., Davis, William B., Lawler, Daniel T., Oppong, Yaa D., Starr, Ryan P., Syndergaard, Scott N., Shelly, Rozeli, Majumder, Mashrur Islam, Sugimoto, Danny, Dugas, Jeffrey, Sr., Rijos, Dolores, Shelton, Sandra, Hong, Stephan, Schwartz, Howard, Sanchez-Crespo, Nelia, Schwartz, Jennifer, Piedra, Terry, Corral, Barbara, Medina, Carmen, Dever, Michael E., Shah, Mitul, Delgado, Michael, Scott, Tameika, Usdan, Lisa S., McGill, Lora J., Arnold, Valerie K., Scatamacchia, Carolyn, Anthony, Codi M., Merchant, Rajan, Yoon, Anelgine C., Hill, Janet, Ng-Price, Lucy, Thompson-Seim, Teri, Ackerman, Ronald, Ackerman, Jamie, Aristy, Florida, Ketter, Nzeera, Finley, Jon, Stull, Mildred, Murray, Monica, Rizvi, Zainab, Guerrero, Sonia, Paliwal, Yogesh K., Paliwal, Amit, Gordon, Sarah, Gordon, Bryan, Montano-Pereira, Cynthia, Galloway, Christopher, Montros, Candice, Aleman, Lily, Shairi, Samira, Van Ever, Wesley, Freeman, George H., Harmon, Esther L., Cross, Marshall A., Sales, Kacie, Gular, Catherine Q., Hepburn, Matthew, Alderson, Nathan, Harshell, Shana, Mahgoub, Siham, Maxwell, Celia, Mellman, Thomas, Thompson, Karl M., Wortman, Glenn, Kingsley, Jeff, Pixler, April, Curry, LaKondria, Afework, Sarah, Swanson, Austin, Jacqmein, Jeffry, Bowers, Maggie, Robison, Dawn, Mosteller, Victoria, Garvey, Janet, Easley, Mary, Kurnat, Rebecca J., Cornelison, Raymond, Gower, Shanda, Schnitz, William, Heinzig-Cartwright, Destiny S., Lewis, Derek, Newton, Fred E., Duhart, Aeiress, Watkins, Breanz, Ball, Brandy, York, Jill, Pickle, Shelby, Musante, David B., Silver, William P., Belhorn, Linda R., Viens, Nicholas A., Dellaero, David, Patel, Priti, Lisec, Kendra, Safirstein, Beth, Zapata, Luz, Gonzalez, Lazaro, Quevedo, Evelyn, Irani, Farah, Grillo, Joseph, Potts, Amy, White, Julie, Flume, Patrick, Headden, Gary, Taylor, Brandie, Warden, Ashley, Chamberlain, Amy, Jeanfreau, Robert, Jeanfreau, Susan, Matherne, Paul G., Caldwell, Amy, Stahl, Jessica, Vowell, Mandy, Newhouse, Lauren, Berthaud, Vladimir, Takizala, Zudi-Mwak, Beninati, Genevieve, Snell, Kimberly, Baker, Sherrie, Walker, James, Harrison, Tavane, Miller, Meagan, Otto, Janet, Gray, Roni, Wilson, Christine, Nemecek, Tiffany, Harrington, Hannah, Eppenbach, Sally, Lewis, Wendell, Bourgeois, Tana, Folsom, Lyndsea, Holt, Gregory, Mirsaeidi, Mehdi, Calderon, Rafael, Lichtenberger, Paola, Quintero, Jalima, Martinez, Becky, Immergluck, Lilly, Johnson, Erica, Chan, Austin, Fas, Norberto, Thomas-Seaton, LaTeshia, Khizer, Saadia, Staben, Jonathan, Beresnev, Tatiana, Jahromi, Maryam, Marovich, Mary A., Hutter, Julia, Nason, Martha, Ledgerwood, Julie, Mascola, John, Leibowitz, Mark, Morales, Fernanda, Delgado, Mike, Sanchez, Rosario, Vega, Norma, Áñez, Germán, Albert, Gary, Coston, Erin, Desai, Chinar, Dunbar, Haoua, Eickhoff, Mark, Garcia, Jenina, Kautz, Margaret, Lee, Angela, Lewis, Maggie, McGarry, Alice, McKnight, Irene, Nelson, Joy, Newingham, Patrick, Price-Abbott, Patty, Reed, Patty, Vegas, Diana, Wilkinson, Bethanie, Smith, Katherine, Woo, Wayne, Cho, Iksung, Glenn, Gregory M., Dubovsky, Filip, Fried, David L., Haughey, Lynne A., Stanton, Ariana C., Rameaka, Lisa Stevens, Rosenberg, David, Tomatsu, Lee, Gonzalez, Viviana, Manalo, Millie, Grunstra, Bernard, Quinn, Donald, Claybrook, Phillip, Olds, Shelby, Dye, Amy, Cannon, Kevin D., Chadwick, Mesha M., Jordan, Bailey, Hussey, Morgan, Nevarez, Hannah, Kelley, Colleen F., Chung, Michael, Moran, Caitlin, Rebolledo, Paulina, Bacher, Christina, Barranco-Santana, Elizabeth, Rodriguez, Jessica, Mendoza, Rafael, Ruperto, Karen, Olivieri, Odette, Ocaña, Enrique, Wylie, Paul E., Henderson, Renea, Jenson, Natasa, Yang, Fan, Kelley, Amy, Finkelstein, Kenneth, Beckmann, David, Hutchins, Tanya, Escallon, Sebastian Garcia, Johnson, Kristen, Sligh, Teresa S., Desai, Parul, Huynh, Vincent, Lopez, Carlos, Mendoza, Erika, Adelglass, Jeffrey, Naifeh, Jerome G., Kucera, Kristine J., Chughtai, Waseem, Jaffer, Shireen H., Davis, Matthew G., Foley, Jennifer, Burgett, Michelle L., Shlotzhauer, Tammi L., Ingalsbe-Geno, Sarah M., Duncanson, Daniel, Kush, Kelly, Nesbitt, Lori, Sonnier, Cora, McCarter, Jennifer, Butcher, Michael B., Fry, James, Percy, Donna, Freudemann, Karen, Gebhardt, Bruce C., Mangu, Padma N., Schroeck, Debra B., Davit, Rajesh K., Hennekes, Gayle D., Luft, Benjamin J., Carr, Melissa, Nachman, Sharon, Pellecchia, Alison, Smith, Candace, Valenti, Bruno, Bermudez, Maria I., Peraita, Noris, Delgado, Ernesto, Arrazcaeta, Alicia, Ramirez, Natalie, Amador, Carmen, Marafioti, Horacio, Dang, Lyly, Clement, Lauren, Berry, Jennifer, Allaw, Mohammed, Geuss, Georgettea, Miles, Chelsea, Bittner, Zachary, Werne, Melody, Calinescu, Cornell, Rodman, Shannon, Rindt, Joshua, Cooksey, Erin, Harrison, Kristina, Cooper, Deanna, Horton, Manisha, Philyaw, Amanda, Jennings, William, Alvarado, Hilario, Baka, Michele, Regalado, Malina, Murray, Linda, Naguib, Sherif, Singletary, Justin, Richmond, Sha-Wanda, Omodele, Sarah, Oppenheim, Emily, Martinez, Reuben, Andriulis, Victoria, Singer, Leonard, Blevins, Jeanne, Thomas, Meagan, Hull, Christine, Pereira, Isabel, Rivero, Gina, Okonya, Tracy, Downing, Frances, Miller, Paulina, Rhee, Margaret, Stapleton, Katherine, Klein, Jeffrey, Hong, Rosamond, Swan, Suzanne, Wahlin, Tami, Bennett, Elizabeth, Salzl, Amy, Phan, Sharine, White, Jewel J., Occhino, Amanda, Paiano, Ruth, McLaughlin, Morgan, Swieboda, Elisa, Garcia-Fragoso, Veronica, Becerra, Maria G., White, Toni, Turley, Christine B., McWilliams, Andrew, Esinhart, Tiffany, Montoya, Natasha, Huskey, Shamika, Paul, Leena, Tashima, Karen, Johnson, Jennie, Neill, Marguerite, Sanchez, Martha, Rybak, Natasha, Mileno, Maria, Cohen, Stuart H., Ruiz, Monica, Boswell, Dean M., Robison, Elizabeth E., Reynolds, Trina L., Neumeister, Sonja, Zorrilla, Carmen D., Rivera, Juana, Ibarra, Jessica, García, Iris, Sierra, Dianca, Ramon, Wanda, Fiorillo, Suzanne, Pitotti, Rebecca, Anderson, Victoria R., Mancilla, Jose Castillo, Le, Nga, Winokur, Patricia L., Ince, Dilek, Hegmann, Theresa, Meier, Jeffrey, Stapleton, Jack, Stulken, Laura, McArthur, Monica, Berry, Andrea, Tapia, Milagritos, Hammershaimb, Elizabeth, Robinson, Toni, MacBryde, Rosa, Kline, Susan, Billings, Joanne L., Cavert, Winston, Forgosh, Les B., Schacker, Timothy W., Bold, Tyler D., Dandachi, Dima, Nelson, Taylor, Bran, Andres, Geiger, Grant, Naqvi, S. Hasan, Florescu, Diana F., Starlin, Richard, Kline, David, Zimmer, Andrea, Abbas, Anum, Wilson, Natasha, Eron, Joseph J., Sciaudone, Michael, Rosengren, A. Lina, Kizer, John S., Rutstein, Sarah E., Bruce, Elizabeth, Espinosa, Claudia, Sanders, Lisa J., Kim, Kami, Casey, Denise, Taylor, Barbara S., Patterson, Thomas, Pinilla, Ruth S., Bullock, Delia, Ponce, Philip, Patterson, Jan, McClelland, R. Scott, Lane, Dakotah C., Wald, Anna, James, Frank, Duke, Elizabeth, Hauge, Kirsten, Heimonen, Jessica, Goecker, Erin A., Huang, Yunda, Fong, Youyi, Kauffman, Carol, Linder, Kathleen, Nofz, Kimberly, McConnell, Andrew, Buynak, Robert J., Webb, Angella, Petty, Taryn, Andree, Stephanie, Sanchez, Erica, Mackey, Nolan, Baudelaire, Clarisse, Dzigiel, Sarah, Marquez, Adrienna, Quillin, Kim, King, Michelle, Abad, Vanessa, Knowles, Jennifer, Waters, Michael, Zepeda, Karla, Coslet, Jordan, Tovar, Dalia, Shaw, Marian E., Turner, Mark A., Huffine, Cory J., Huffine, Esther S., Ake, Julie A., Secord, Elizabeth, McGrath, Eric, Levy, Phillip, Stewart, Brittany, Cromer, Charnell, Walters, Ayanna, Ellsworth, Grant, Greene, Caroline, Galloway, Sarah, Kapadia, Shashi, DeHaan, Elliot, Wilson, Clint, Milligan, Jason, Raley, Danielle, Bocchini, Joseph, McClenathan, Bruce, Hussain, Mary, Lomasney, Evelyn, Hall, Evelyn, Lamberth, Sherry, Schmeck, Christy, Leathers, Vickie, Theodore, Deborah A., Branche, Angela R., Graciaa, Daniel S., Hatlen, Timothy J., Miller, Jacqueline, Sadoff, Jerald, Falsey, Ann R., Sobieszczyk, Magdalena E., Rick, Anne-Marie, Laurens, Matthew B., Huang, Ying, Yu, Chenchen, Martin, Thomas C.S., Rodriguez, Carina A., Rostad, Christina A., Maboa, Rebone M., Baden, Lindsey R., El Sahly, Hana M., Grinsztejn, Beatriz, Gray, Glenda E., Gay, Cynthia L., Gilbert, Peter B., Janes, Holly E., Kublin, James G., Leav, Brett, Hirsch, Ian, Struyf, Frank, Dunkle, Lisa M., Neuzil, Kathleen M., Corey, Lawrence, Goepfert, Paul A., Follmann, Dean, and Kotloff, Karen L.

Published
2023
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16. African American/black race, Apolipoprotein L1, and the indirect glomerular filtration measure serum creatinine among persons living with HIV

Author

Shelton, Brittany A., Sawinski, Deirdre, Peter, Inga, Maclennan, Paul A., Pelletier, Nicole F., Nadkarni, Girish, Julian, Bruce, Saag, Michael, Fatima, Huma, Crane, Heidi, Lee, Wonjun, Moore, Richard D., Christopoulos, Katerina, Jacobson, Jeffrey M., Eron, Joseph J., Kumar, Vineeta, and Locke, Jayme E.

Published
2023
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17. PREVALENCE AND CORRELATES OF SARS-COV-2 VACCINE UPTAKE AND HESITANCY AMONG PEOPLE WITH HIV ACROSS THE U.S.

Author

Spinelli, Matthew A., primary, Johnson, Mallory O., additional, Lisha, Nadra E., additional, Jain, Jennifer P., additional, Moreira, Carlos V., additional, Glidden, David V., additional, Burkholder, Greer A., additional, Crane, Heidi M., additional, Jacobson, Jeffrey M., additional, Cachay, Edward R., additional, Mayer, Kenneth H., additional, Napravnik, Sonia, additional, Moore, Richard D., additional, Gandhi, Monica, additional, and Christopoulos, Katerina A., additional

Published
2024
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18. Alcohol consumption upon direct-acting antiviral therapy for hepatitis C among persons with human immunodeficiency virus in the United States

Author

Chen, Po-Hung, Yenokyan, Karine, Fojo, Anthony T., Hutton, Heidi E., Lesko, Catherine R., McCaul, Mary E., Yang, Cui, Cachay, Edward R., Crane, Heidi M., Jacobson, Jeffrey M., Kim, H. Nina, Kitahata, Mari M., Mayer, Kenneth H., Moore, Richard D., Napravnik, Sonia, Saag, Michael, Lau, Bryan, and Chander, Geetanjali

Published
2022
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19. Associations between female birth sex and risk of chronic kidney disease development among people with HIV in the USA: A longitudinal, multicentre, cohort study

Author

Shelton, Brittany A., Sawinski, Deirdre, MacLennan, Paul A., Lee, Wonjun, Wyatt, Christina, Nadkarni, Girish, Fatima, Huma, Mehta, Shikha, Crane, Heidi M., Porrett, Paige, Julian, Bruce, Moore, Richard D., Christopoulos, Katerina, Jacobson, Jeffrey M., Muller, Elmi, Eron, Joseph J., Saag, Michael, Peter, Inga, and Locke, Jayme E.

Published
2022
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20. Self‐reported hepatitis B testing among noninstitutionalized adults in the United States before the implementation of universal screening, 2013–2017: A nationwide population‐based study.

Author

Yendewa, George A., Salata, Robert A., Olasehinde, Temitope, Mulindwa, Frank, Jacobson, Jeffrey M., and Mohareb, Amir M.

Subjects
HEPATITIS B vaccines, MEDICAL screening, HEPATITIS B, POISSON regression, HEPATITIS C, HEPATITIS B virus, HIV testing kits
Abstract

In 2023, the US Centers for Disease Control and Prevention recommended universal screening for hepatitis B virus (HBV); however, the proportion of US adults screened before implementing this recommendation is unknown. We analysed nationally representative data from the National Health Interview Survey (2013–2017) on self‐reported HBV testing among noninstitutionalized US adults ≥18 years. We employed Poisson logistic regression to identify factors associated with self‐reported testing, using a conceptual framework that included four overarching factors: sociodemographic characteristics, healthcare access, health‐seeking behaviours and experiences, and access to internet‐based health information. Among 149,628 survey respondents, the self‐reported HBV testing rate was 27.2% (95% CI 26.2–28.7) and increased by 1.7% from 2013 to 2017 (p =.006). In adjusted analysis, health‐seeking behaviours and experiences had the strongest associations of self‐reported testing including a history of hepatitis (AOR 2.68, 95% CI 1.92–3.73), receipt of hepatitis B vaccination (AOR 5.11, 95% CI 4.61–5.68) and prior testing for hepatitis C (AOR 9.14, 95% CI 7.97–10.48) and HIV (AOR 2.69, 95% CI 2.44–2.97). Other factors associated with testing included being male (AOR 1.14, 95% CI 1.03–1.26), ages 30–44 years (AOR 1.37, 95% CI 1.17–1.61), 45–60 years (AOR 1.55, 95% CI 1.30–1.80) and ≥60 years (AOR 1.53, 95% CI 1.28–1.84), residence in the Western US region (AOR 1.23, 95% CI 1.06–1.43), and access to internet‐based health information (AOR 1.32, 95% CI 1.18–1.47). Being Hispanic was associated with lower odds of testing (AOR 0.80, 95% CI 0.66–0.97). These findings may help guide optimal HBV screening in the universal testing era. [ABSTRACT FROM AUTHOR]

Published
2024
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22. The Control of HIV After Antiretroviral Medication Pause (CHAMP) Study: Posttreatment Controllers Identified From 14 Clinical Studies

Author

Namazi, Golnaz, Fajnzylber, Jesse M, Aga, Evgenia, Bosch, Ronald J, Acosta, Edward P, Sharaf, Radwa, Hartogensis, Wendy, Jacobson, Jeffrey M, Connick, Elizabeth, Volberding, Paul, Skiest, Daniel, Margolis, David, Sneller, Michael C, Little, Susan J, Gianella, Sara, Smith, Davey M, Kuritzkes, Daniel R, Gulick, Roy M, Mellors, John W, Mehraj, Vikram, Gandhi, Rajesh T, Mitsuyasu, Ronald, Schooley, Robert T, Henry, Keith, Tebas, Pablo, Deeks, Steven G, Chun, Tae-Wook, Collier, Ann C, Routy, Jean-Pierre, Hecht, Frederick M, Walker, Bruce D, and Li, Jonathan Z

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Immunology, Clinical Research, HIV/AIDS, Sexually Transmitted Infections, Infectious Diseases, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Adult, Anti-HIV Agents, CD4 Lymphocyte Count, Drug Administration Schedule, Female, HIV Infections, HIV-1, Humans, Male, Middle Aged, Viral Load, Biological Sciences, Medical and Health Sciences, Microbiology, Biological sciences, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundHIV posttreatment controllers are rare individuals who start antiretroviral therapy (ART), but maintain HIV suppression after treatment interruption. The frequency of posttreatment control and posttreatment interruption viral dynamics have not been well characterized.MethodsPosttreatment controllers were identified from 14 studies and defined as individuals who underwent treatment interruption with viral loads ≤400 copies/mL at two-thirds or more of time points for ≥24 weeks. Viral load and CD4+ cell dynamics were compared between posttreatment controllers and noncontrollers.ResultsOf the 67 posttreatment controllers identified, 38 initiated ART during early HIV infection. Posttreatment controllers were more frequently identified in those treated during early versus chronic infection (13% vs 4%, P < .001). In posttreatment controllers with weekly viral load monitoring, 45% had a peak posttreatment interruption viral load of ≥1000 copies/mL and 33% had a peak viral load ≥10000 copies/mL. Of posttreatment controllers, 55% maintained HIV control for 2 years, with approximately 20% maintaining control for ≥5 years.ConclusionsPosttreatment control was more commonly identified amongst early treated individuals, frequently characterized by early transient viral rebound and heterogeneous durability of HIV remission. These results may provide mechanistic insights and have implications for the design of trials aimed at achieving HIV remission.

Published
2018

23. HIV-1 proviral landscapes distinguish posttreatment controllers from noncontrollers

Author

Sharaf, Radwa, Lee, Guinevere Q, Sun, Xiaoming, Etemad, Behzad, Aboukhater, Layla M, Hu, Zixin, Brumme, Zabrina L, Aga, Evgenia, Bosch, Ronald J, Wen, Ying, Namazi, Golnaz, Gao, Ce, Acosta, Edward P, Gandhi, Rajesh T, Jacobson, Jeffrey M, Skiest, Daniel, Margolis, David M, Mitsuyasu, Ronald, Volberding, Paul, Connick, Elizabeth, Kuritzkes, Daniel R, Lederman, Michael M, Yu, Xu G, Lichterfeld, Mathias, and Li, Jonathan Z

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Immunology, Sexually Transmitted Infections, Infectious Diseases, HIV/AIDS, Genetics, Infection, Adult, Anti-HIV Agents, Defective Viruses, Disease Reservoirs, Female, Genome, Viral, HIV Infections, HIV Long-Term Survivors, HIV-1, Humans, Male, Middle Aged, Proviruses, Viral Load, AIDS vaccine, AIDS/HIV, Infectious disease, Medical and Health Sciences, Biological sciences, Biomedical and clinical sciences, Health sciences
Abstract

HIV posttreatment controllers (PTCs) represent a natural model of sustained HIV remission, but they are rare and little is known about their viral reservoir. We obtained 1,450 proviral sequences after near-full-length amplification for 10 PTCs and 16 posttreatment noncontrollers (NCs). Before treatment interruption, the median intact and total reservoir size in PTCs was 7-fold lower than in NCs, but the proportion of intact, defective, and total clonally expanded proviral genomes was not significantly different between the 2 groups. Quantification of total but not intact proviral genome copies predicted sustained HIV remission as 81% of NCs, but none of the PTCs had a total proviral genome greater than 4 copies per million peripheral blood mononuclear cells (PBMCs). The results highlight the restricted intact and defective HIV reservoir in PTCs and suggest that total proviral genome burden could act as the first biomarker for identifying PTCs. Total and defective but not intact proviral copy numbers correlated with levels of cell-associated HIV RNA, activated NK cell percentages, and both HIV-specific CD4+ and CD8+ responses. These results support the concept that defective HIV genomes can lead to viral antigen production and interact with both the innate and adaptive immune systems.

Published
2018

24. Effect of Short-Term Antiretroviral Therapy Interruption on Levels of Integrated HIV DNA

Author

Strongin, Zachary, Sharaf, Radwa, VanBelzen, D Jake, Jacobson, Jeffrey M, Connick, Elizabeth, Volberding, Paul, Skiest, Daniel J, Gandhi, Rajesh T, Kuritzkes, Daniel R, O'Doherty, Una, and Li, Jonathan Z

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Immunology, Infectious Diseases, Clinical Research, HIV/AIDS, Sexually Transmitted Infections, Clinical Trials and Supportive Activities, 5.1 Pharmaceuticals, 6.1 Pharmaceuticals, Infection, Anti-HIV Agents, DNA, Viral, HIV Infections, HIV-1, Humans, Leukocytes, Mononuclear, Proviruses, Viral Load, Virus Integration, Withholding Treatment, assay, HIV, integrated DNA, reservoir, treatment interruption, Biological Sciences, Agricultural and Veterinary Sciences, Medical and Health Sciences, Virology, Agricultural, veterinary and food sciences, Biological sciences, Biomedical and clinical sciences
Abstract

Analytic treatment interruption (ATI) studies are required to evaluate strategies aimed at achieving ART-free HIV remission, but the impact of ATI on the viral reservoir remains unclear. We validated a DNA size selection-based assay for measuring levels of integrated HIV DNA and applied it to assess the effects of short-term ATI on the HIV reservoir. Samples from participants from four AIDS Clinical Trials Group ATI studies were assayed for integrated HIV DNA levels. Cryopreserved peripheral blood mononuclear cells (PBMCs) were obtained for 12 participants with available samples pre-ATI and approximately 6 months after ART resumption. Four participants also had samples available during the ATI. The median duration of ATI was 12 weeks. Validation of the HIV integrated DNA size-exclusion (HIDE) assay was performed using samples spiked with unintegrated HIV DNA, HIV-infected cell lines, and participant PBMCs. The HIDE assay eliminated 99% of unintegrated HIV DNA species and strongly correlated with the established Alu-gag assay. For the majority of individuals, integrated DNA levels increased during ATI and subsequently declined upon ART resumption. There was no significant difference in the levels of integrated HIV DNA between the pre- and post-ATI time points, with a median ratio of post- to pre-ATI HIV DNA levels of 0.95. Using a new integrated HIV DNA assay, we found minimal change in the levels of integrated HIV DNA in participants who underwent an ATI, followed by 6 months of ART. This suggests that short-term ATI can be conducted without a significant impact on the levels of integrated proviral DNA in the peripheral blood.IMPORTANCE Interventions aimed at achieving sustained antiretroviral therapy (ART)-free HIV remission require treatment interruption trials to assess their efficacy. However, these trials are accompanied by safety concerns related to the expansion of the viral reservoir. We validated an assay that uses an automated DNA size-selection platform for quantifying levels of integrated HIV DNA and is less sample- and labor-intensive than current assays. Using stored samples from AIDS Clinical Trials Group studies, we found that short-term ART discontinuation had minimal impact on integrated HIV DNA levels after ART resumption, providing reassurance about the reservoir effects of short-term treatment interruption trials.

Published
2018

25. Effective and targeted latency reversal in CD4 + T cells from individuals on long term combined antiretroviral therapy initiated during chronic HIV-1 infection

Author

Ngo, Minh Ha, primary, Pankrac, Joshua, additional, Ho, Ryan C. Y., additional, Ndashimye, Emmanuel, additional, Pawa, Rahul, additional, Ceccacci, Renata, additional, Biru, Tsigereda, additional, Olabode, Abayomi S., additional, Klein, Katja, additional, Li, Yue, additional, Kovacs, Colin, additional, Assad, Robert, additional, Jacobson, Jeffrey M., additional, Canaday, David H., additional, Tomusange, Stephen, additional, Jamiru, Samiri, additional, Anok, Aggrey, additional, Kityamuweesi, Taddeo, additional, Buule, Paul, additional, Galiwango, Ronald M., additional, Reynolds, Steven J., additional, Quinn, Thomas C., additional, Redd, Andrew D., additional, Prodger, Jessica L., additional, Mann, Jamie F. S., additional, and Arts, Eric J., additional

Published
2024
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26. Effective and targeted latency reversal in CD4+ T cells from individuals on long term combined antiretroviral therapy initiated during chronic HIV-1 infection.

Author

Minh Ha Ngo, Pankrac, Joshua, Ho, Ryan C. Y., Ndashimye, Emmanuel, Pawa, Rahul, Ceccacci, Renata, Biru, Tsigereda, Olabode, Abayomi S., Klein, Katja, Yue Li, Kovacs, Colin, Assad, Robert, Jacobson, Jeffrey M., Canaday, David H., Tomusange, Stephen, Jamiru, Samiri, Anok, Aggrey, Kityamuweesi, Taddeo, Buule, Paul, and Galiwango, Ronald M.

Published
2024
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27. Prevalence of hepatitis B surface antigen and serological markers of other endemic infections in HIV-infected children, adolescents and pregnant women in Sierra Leone: A cross-sectional study

Author

Yendewa, George A., Lakoh, Sulaiman, Yendewa, Sahr A., Bangura, Khadijah, Lawrence, Hannah, Patiño, Lucia, Jiba, Darlinda F., Vandy, Alren O., Murray, Mariama J.S., Massaquoi, Samuel P., Deen, Gibrilla F., Sahr, Foday, Hoffmann, Christopher J., Jacobson, Jeffrey M., Poveda, Eva, Aguilera, Antonio, and Salata, Robert A.

Published
2021
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29. Effect of Patient Navigation With or Without Financial Incentives on Viral Suppression Among Hospitalized Patients With HIV Infection and Substance Use: A Randomized Clinical Trial

Author

Metsch, Lisa R, Feaster, Daniel J, Gooden, Lauren, Matheson, Tim, Stitzer, Maxine, Das, Moupali, Jain, Mamta K, Rodriguez, Allan E, Armstrong, Wendy S, Lucas, Gregory M, Nijhawan, Ank E, Drainoni, Mari-Lynn, Herrera, Patricia, Vergara-Rodriguez, Pamela, Jacobson, Jeffrey M, Mugavero, Michael J, Sullivan, Meg, Daar, Eric S, McMahon, Deborah K, Ferris, David C, Lindblad, Robert, VanVeldhuisen, Paul, Oden, Neal, Castellón, Pedro C, Tross, Susan, Haynes, Louise F, Douaihy, Antoine, Sorensen, James L, Metzger, David S, Mandler, Raul N, Colfax, Grant N, and del Rio, Carlos

Subjects
HIV/AIDS, Prevention, Infectious Diseases, Health Services, Comparative Effectiveness Research, Clinical Trials and Supportive Activities, Clinical Research, Rehabilitation, Substance Misuse, Infection, Good Health and Well Being, Adult, Case Management, Child, Child, Preschool, Female, Financing, Personal, HIV Infections, HIV-1, Humans, Infant, Inpatients, Male, Middle Aged, Motivation, Motivational Interviewing, Patient Navigation, Substance-Related Disorders, Treatment Outcome, Viral Load, Medical and Health Sciences, General & Internal Medicine
Abstract

ImportanceSubstance use is a major driver of the HIV epidemic and is associated with poor HIV care outcomes. Patient navigation (care coordination with case management) and the use of financial incentives for achieving predetermined outcomes are interventions increasingly promoted to engage patients in substance use disorders treatment and HIV care, but there is little evidence for their efficacy in improving HIV-1 viral suppression rates.ObjectiveTo assess the effect of a structured patient navigation intervention with or without financial incentives to improve HIV-1 viral suppression rates among patients with elevated HIV-1 viral loads and substance use recruited as hospital inpatients.Design, setting, and participantsFrom July 2012 through January 2014, 801 patients with HIV infection and substance use from 11 hospitals across the United States were randomly assigned to receive patient navigation alone (n = 266), patient navigation plus financial incentives (n = 271), or treatment as usual (n = 264). HIV-1 plasma viral load was measured at baseline and at 6 and 12 months.InterventionsPatient navigation included up to 11 sessions of care coordination with case management and motivational interviewing techniques over 6 months. Financial incentives (up to $1160) were provided for achieving targeted behaviors aimed at reducing substance use, increasing engagement in HIV care, and improving HIV outcomes. Treatment as usual was the standard practice at each hospital for linking hospitalized patients to outpatient HIV care and substance use disorders treatment.Main outcomes and measuresThe primary outcome was HIV viral suppression (≤200 copies/mL) relative to viral nonsuppression or death at the 12-month follow-up.ResultsOf 801 patients randomized, 261 (32.6%) were women (mean [SD] age, 44.6 years [10.0 years]). There were no differences in rates of HIV viral suppression versus nonsuppression or death among the 3 groups at 12 months. Eighty-five of 249 patients (34.1%) in the usual-treatment group experienced treatment success compared with 89 of 249 patients (35.7%) in the navigation-only group for a treatment difference of 1.6% (95% CI, -6.8% to 10.0%; P = .80) and compared with 98 of 254 patients (38.6%) in the navigation-plus-incentives group for a treatment difference of 4.5% (95% CI -4.0% to 12.8%; P = .68). The treatment difference between the navigation-only and the navigation-plus-incentives group was -2.8% (95% CI, -11.3% to 5.6%; P = .68).Conclusions and relevanceAmong hospitalized patients with HIV infection and substance use, patient navigation with or without financial incentives did not have a beneficial effect on HIV viral suppression relative to nonsuppression or death at 12 months vs treatment as usual. These findings do not support these interventions in this setting.Trial registrationclinicaltrials.gov Identifier: NCT01612169.

Published
2016

30. IL-15 promotes activation and expansion of CD8+ T cells in HIV-1 infection

Author

Younes, Souheil-Antoine, Freeman, Michael L, Mudd, Joseph C, Shive, Carey L, Reynaldi, Arnold, Panigrahi, Soumya, Estes, Jacob D, Deleage, Claire, Lucero, Carissa, Anderson, Jodi, Schacker, Timothy W, Davenport, Miles P, McCune, Joseph M, Hunt, Peter W, Lee, Sulggi A, Serrano-Villar, Sergio, Debernardo, Robert L, Jacobson, Jeffrey M, Canaday, David H, Sekaly, Rafick-Pierre, Rodriguez, Benigno, Sieg, Scott F, and Lederman, Michael M

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Immunology, Sexually Transmitted Infections, HIV/AIDS, Clinical Research, Infectious Diseases, Health Disparities, Minority Health, Women's Health, 2.1 Biological and endogenous factors, Aetiology, Infection, Good Health and Well Being, Adult, Aged, Animals, Anti-Retroviral Agents, Biopsy, CD8-Positive T-Lymphocytes, Case-Control Studies, Cell Proliferation, Female, Granzymes, HIV Infections, HIV-1, Haplotypes, Humans, Interleukin-15, Ki-67 Antigen, Leukocyte Common Antigens, Leukocytes, Mononuclear, Lymph Nodes, Lymphocyte Activation, Male, Mice, Middle Aged, Phenotype, Receptors, CCR7, Medical and Health Sciences, Biological sciences, Biomedical and clinical sciences, Health sciences
Abstract

In HIV-1-infected patients, increased numbers of circulating CD8+ T cells are linked to increased risk of morbidity and mortality. Here, we identified a bystander mechanism that promotes CD8 T cell activation and expansion in untreated HIV-1-infected patients. Compared with healthy controls, untreated HIV-1-infected patients have an increased population of proliferating, granzyme B+, CD8+ T cells in circulation. Vβ expression and deep sequencing of CDR3 revealed that in untreated HIV-1 infection, cycling memory CD8 T cells possess a broad T cell repertoire that reflects the repertoire of the resting population. This suggests that cycling is driven by bystander activation, rather than specific antigen exposure. Treatment of peripheral blood mononuclear cells with IL-15 induced a cycling, granzyme B+ phenotype in CD8+ T cells. Moreover, elevated IL-15 expression in the lymph nodes of untreated HIV-1-infected patients correlated with circulating CD8+ T cell counts and was normalized in these patients following antiretroviral therapy. Together, these results suggest that IL-15 drives bystander activation of CD8+ T cells, which predicts disease progression in untreated HIV-1-infected patients and suggests that elevated IL-15 may also drive CD8+ T cell expansion that is linked to increased morbidity and mortality in treated patients.

Published
2016

31. Dendritic Cell Immunotherapy for HIV-1 Infection Using Autologous HIV-1 RNA

Author

Jacobson, Jeffrey M, Routy, Jean-Pierre, Welles, Seth, DeBenedette, Mark, Tcherepanova, Irina, Angel, Jonathan B, Asmuth, David M, Stein, David K, Baril, Jean-Guy, McKellar, Mehri, Margolis, David M, Trottier, Benoit, Wood, Kenneth, and Nicolette, Charles

Subjects
Infectious Diseases, HIV/AIDS, Immunization, Vaccine Related, Clinical Trials and Supportive Activities, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Infection, Good Health and Well Being, Adolescent, Adult, CD4 Lymphocyte Count, CD4-Positive T-Lymphocytes, Dendritic Cells, Double-Blind Method, Female, Granzymes, HIV Infections, HIV-1, Humans, Immunotherapy, Interferon-gamma, Interleukin-2, Lysosomal-Associated Membrane Protein 1, Male, Middle Aged, Placebos, RNA, Viral, T-Lymphocytes, Cytotoxic, Tumor Necrosis Factor-alpha, Viral Load, Young Adult, gag Gene Products, Human Immunodeficiency Virus, nef Gene Products, Human Immunodeficiency Virus, rev Gene Products, Human Immunodeficiency Virus, vpr Gene Products, Human Immunodeficiency Virus, HIV, therapeutic immunization, dendritic cell therapy, autologous antigen, functional cure, Clinical Sciences, Public Health and Health Services, Virology
Abstract

BackgroundThe genomic heterogeneity of HIV-1 impedes the ability of consensus sequences in vaccines to elicit effective antiviral immune responses. AGS-004 amplifies translation-competent RNA molecules encoding for Gag, Rev, Vpr, and Nef from the patient's autologous virus and loads them into dendritic cells.MethodsThis phase IIB, multicenter, 2:1 randomized, double-blind, placebo-controlled study enrolled 54 HIV-1-infected patients on antiretroviral therapy with viral loads (VLs) 450 cells per cubic millimeter, and nadir counts >200 cells per cubic millimeter, to receive intradermal injections of study product into the axillary lymph node region every 4 weeks. At week 16, a 12-week analytical treatment interruption (ATI) was undertaken.ResultsThere was no difference in the end-of-ATI VL (average of values from weeks 11 and 12) between the 2 arms of the study [4.39 (4.17, 4.69) vs. 4.47 (3.76, 4.64) log10 HIV-1 RNA; P = 0.73]. Between arms, no change between pre-antiretroviral therapy VL and the end-of-ATI VL [-0.06 (0.24, -0.32) vs. -0.17 (0.17, -0.32) log10 HIV-1 RNA; P = 0.43] was observed. When interferon-γ, interleukin-2, tumor necrosis factor α, CD107a, and granzyme b expressions were measured by multicolor flow cytometry, a greater percentage of AGS-004 than of placebo recipients had multifunctional cytotoxic T-lymphocyte responses induced in the CD28+/CD45RA-CD8 effector/memory T-cell population to dendritic cells electroporated with autologous antigens. Adverse events consisted of transient, mild (grade 1) local injection site reactions.ConclusionsDespite the induction of HIV-specific effector/memory CD8 T-cell responses, no antiviral effect was seen after the administration of AGS-004 when compared with placebo.

Published
2016

32. Dendritic Cell Immunotherapy for HIV-1 Infection Using Autologous HIV-1 RNA: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Author

Jacobson, Jeffrey M, Routy, Jean-Pierre, Welles, Seth, DeBenedette, Mark, Tcherepanova, Irina, Angel, Jonathan B, Asmuth, David M, Stein, David K, Baril, Jean-Guy, McKellar, Mehri, Margolis, David M, Trottier, Benoit, Wood, Kenneth, and Nicolette, Charles

Subjects
Dendritic Cells, CD4-Positive T-Lymphocytes, T-Lymphocytes, Cytotoxic, Humans, HIV-1, HIV Infections, Tumor Necrosis Factor-alpha, RNA, Viral, Interleukin-2, Placebos, CD4 Lymphocyte Count, Immunotherapy, Viral Load, Double-Blind Method, Adolescent, Adult, Middle Aged, Female, Male, Lysosomal-Associated Membrane Protein 1, Granzymes, gag Gene Products, Human Immunodeficiency Virus, nef Gene Products, Human Immunodeficiency Virus, rev Gene Products, Human Immunodeficiency Virus, vpr Gene Products, Human Immunodeficiency Virus, Interferon-gamma, Young Adult, T-Lymphocytes, Cytotoxic, RNA, Viral, gag Gene Products, Human Immunodeficiency Virus, nef Gene Products, rev Gene Products, vpr Gene Products, Virology, Clinical Sciences, Public Health and Health Services
Abstract

BackgroundThe genomic heterogeneity of HIV-1 impedes the ability of consensus sequences in vaccines to elicit effective antiviral immune responses. AGS-004 amplifies translation-competent RNA molecules encoding for Gag, Rev, Vpr, and Nef from the patient's autologous virus and loads them into dendritic cells.MethodsThis phase IIB, multicenter, 2:1 randomized, double-blind, placebo-controlled study enrolled 54 HIV-1-infected patients on antiretroviral therapy with viral loads (VLs) 450 cells per cubic millimeter, and nadir counts >200 cells per cubic millimeter, to receive intradermal injections of study product into the axillary lymph node region every 4 weeks. At week 16, a 12-week analytical treatment interruption (ATI) was undertaken.ResultsThere was no difference in the end-of-ATI VL (average of values from weeks 11 and 12) between the 2 arms of the study [4.39 (4.17, 4.69) vs. 4.47 (3.76, 4.64) log10 HIV-1 RNA; P = 0.73]. Between arms, no change between pre-antiretroviral therapy VL and the end-of-ATI VL [-0.06 (0.24, -0.32) vs. -0.17 (0.17, -0.32) log10 HIV-1 RNA; P = 0.43] was observed. When interferon-γ, interleukin-2, tumor necrosis factor α, CD107a, and granzyme b expressions were measured by multicolor flow cytometry, a greater percentage of AGS-004 than of placebo recipients had multifunctional cytotoxic T-lymphocyte responses induced in the CD28+/CD45RA-CD8 effector/memory T-cell population to dendritic cells electroporated with autologous antigens. Adverse events consisted of transient, mild (grade 1) local injection site reactions.ConclusionsDespite the induction of HIV-specific effector/memory CD8 T-cell responses, no antiviral effect was seen after the administration of AGS-004 when compared with placebo.

Published
2016

33. The immunogenicity of an HIV-1 gag conserved element DNA vaccine in people with HIV and receiving antiretroviral therapy

Author

Jacobson, Jeffrey M., primary, Felber, Barbara K., additional, Chen, Huichao, additional, Pavlakis, George N., additional, Mullins, James I., additional, de Rosa, Stephen C., additional, Kuritzkes, Daniel R., additional, Tomaras, Georgia D., additional, Kinslow, Jennifer, additional, Bao, Yajing, additional, Olefsky, Maxine, additional, Rosati, Margherita, additional, Bear, Jenifer, additional, Hannaman, Drew, additional, Laird, Gregory M., additional, Cyktor, Joshua C., additional, Heath, Sonya L., additional, Collier, Ann C., additional, Koletar, Susan L., additional, Taiwo, Babafemi O., additional, Tebas, Pablo, additional, Wohl, David A., additional, belanzauran-Zamudio, Pablo F., additional, Mcelrath, M. Juliana, additional, and Landay, Alan L., additional

Published
2023
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38. Sevelamer Does Not Decrease Lipopolysaccharide or Soluble CD14 Levels But Decreases Soluble Tissue Factor, Low-Density Lipoprotein (LDL) Cholesterol, and Oxidized LDL Cholesterol Levels in Individuals With Untreated HIV Infection

Author

Sandler, Netanya G, Zhang, Xinyan, Bosch, Ronald J, Funderburg, Nicholas T, Choi, Andrew I, Robinson, Janet K, Fine, Derek M, Coombs, Robert W, Jacobson, Jeffrey M, Landay, Alan L, Douek, Daniel C, Tressler, Randall, Read, Sarah W, Wilson, Cara C, Deeks, Steven G, Lederman, Michael M, Gandhi, Rajesh T, Tiu, Jennifer, Janik, Jennifer, Ebiasah, Ruth, Sise, Thucuma, Morse, Gene, Bishopric, George, Klebert, Michael, Borowski, LuAnn, Harding, Paul, Gonzalez, Amy, Tracy, Russell, Claggett, Brian, Alvarez, Alicarmen, James, Tamara, Walton, Patricia, Allen, Kristen, Daar, Eric, Lopez, Ruben, Tebas, Pablo, Thomas, Aleshia, Sbrolla, Amy, Flynn, Teri, Whitely, Kim, Davis, Traci, McGregor, Donna, Taiwo, Babafemi, Hurley, Christine, Lake, Jordan, Luetkemeyer, Annie, Smith, Anna, Fichtenbaum, Carl J, Stockton, Jan M, Griesmer, Kristine, Ray, Graham, Bolivar, Hector H, Fischl, Margaret A, Adams, Mary, Klebert, Michael K, and Royal, Michael

Subjects
HIV/AIDS, Cardiovascular, Infectious Diseases, Clinical Research, Heart Disease, Atherosclerosis, Evaluation of treatments and therapeutic interventions, 2.1 Biological and endogenous factors, 6.1 Pharmaceuticals, Aetiology, Infection, Good Health and Well Being, Adult, Bacterial Translocation, Cardiovascular Agents, Cardiovascular Diseases, Cholesterol, LDL, HIV Infections, Humans, Lipopolysaccharide Receptors, Lipopolysaccharides, Lipoproteins, LDL, Male, Middle Aged, Polyamines, Sevelamer, Thromboplastin, Treatment Outcome, Young Adult, HIV, sevelamer, microbial translocation, LPS, sCD14, soluble tissue factor, LDL, oxLDL, AIDS Clinical Trials Group A5296 Team, Biological Sciences, Medical and Health Sciences, Microbiology
Abstract

UnlabelledAbnormal levels of inflammation are associated with cardiovascular disease and mortality in human immunodeficiency virus (HIV)-infected patients. Microbial translocation, which may cause inflammation, is decreased by sevelamer in patients undergoing hemodialysis. In this single-arm study, we evaluated the effects of 8 weeks of sevelamer therapy on 36 HIV-infected subjects who were not receiving antiretroviral therapy. Sevelamer did not significantly change markers of microbial translocation, inflammation, or T-cell activation. During sevelamer treatment, however, levels of soluble tissue factor, low-density lipoprotein (LDL) cholesterol, and oxidized LDL cholesterol decreased significantly, whereas D-dimer levels increased. Thus, in this study population, sevelamer did not reduce microbial translocation but may have yielded cardiovascular benefits.Clinical trials registrationNCT 01543958.

Published
2014

39. Viral Suppression Trajectories Destabilized After Coronavirus Disease 2019 Among US People With Human Immunodeficiency Virus: An Interrupted Time Series Analysis.

Author

Spinelli, Matthew A, Christopoulos, Katerina A, Moreira, Carlos V, Jain, Jennifer P, Lisha, Nadra, Glidden, David V, Burkholder, Greer A, Crane, Heidi M, Shapiro, Adrienne E, Jacobson, Jeffrey M, Cachay, Edward R, Mayer, Kenneth H, Napravnik, Sonia, Moore, Richard D, Gandhi, Monica, and Johnson, Mallory O

Subjects
HIV prevention, VIRAL load, RESEARCH funding, HIV-positive persons, TIME series analysis, LONGITUDINAL method, RACE, RESEARCH, COVID-19 pandemic
Abstract

We examined changes in the proportion of people with human immunodeficiency virus (PWH) with virologic suppression (VS) in a multisite US cohort before and since the coronavirus disease 2019 (COVID-19) pandemic. Overall, prior gains in VS slowed during COVID-19, with disproportionate impacts on Black PWH and PWH who inject drugs. [ABSTRACT FROM AUTHOR]

Published
2024
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40. Viral Suppression Trajectories Destabilized After Coronavirus Disease 2019 Among US People With Human Immunodeficiency Virus: An Interrupted Time Series Analysis

Author

Spinelli, Matthew A, primary, Christopoulos, Katerina A, additional, Moreira, Carlos V, additional, Jain, Jennifer P, additional, Lisha, Nadra, additional, Glidden, David V, additional, Burkholder, Greer A, additional, Crane, Heidi M, additional, Shapiro, Adrienne E, additional, Jacobson, Jeffrey M, additional, Cachay, Edward R, additional, Mayer, Kenneth H, additional, Napravnik, Sonia, additional, Moore, Richard D, additional, Gandhi, Monica, additional, and Johnson, Mallory O, additional

Published
2023
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41. Assessing the associations between known genetic variants and substance use in people with HIV in the United States

Author

Haas, Cameron B., primary, Jordahl, Kristina M., additional, Nance, Robin M., additional, Whitney, Bridget M., additional, Wang, Lu, additional, Delaney, Joseph A. C., additional, Ruderman, Stephanie, additional, Jia, Tongqiu, additional, Mathews, Wm. Christopher, additional, Saag, Michael S., additional, Lee, Sulggi A., additional, Napravnik, Sonia, additional, Jacobson, Jeffrey M., additional, Chander, Geetanjali, additional, McCall, Elizabeth M., additional, Moore, Richard D., additional, Mayer, Kenneth H., additional, Mukherjee, Shubhabrata, additional, Lee, Won Jun, additional, Crane, Paul K., additional, Crane, Heidi, additional, Peter, Inga, additional, and Lindström, Sara, additional

Published
2023
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42. Risk of COVID-19 after natural infection or vaccination

Author

Rick, Anne-Marie, primary, Laurens, Matthew B., additional, Huang, Ying, additional, Yu, Chenchen, additional, Martin, Thomas C.S., additional, Rodriguez, Carina A., additional, Rostad, Christina A., additional, Maboa, Rebone M., additional, Baden, Lindsey R., additional, El Sahly, Hana M., additional, Grinsztejn, Beatriz, additional, Gray, Glenda E., additional, Gay, Cynthia L., additional, Gilbert, Peter B., additional, Janes, Holly E., additional, Kublin, James G., additional, Huang, Yunda, additional, Leav, Brett, additional, Hirsch, Ian, additional, Struyf, Frank, additional, Dunkle, Lisa M., additional, Neuzil, Kathleen M., additional, Corey, Lawrence, additional, Goepfert, Paul A., additional, Walsh, Stephen R., additional, Follmann, Dean, additional, Kotloff, Karen L., additional, Adams, Atoya, additional, Miller, Eric, additional, Rankin, Bruce G., additional, Shinn, Steven, additional, Nash, Marshall, additional, Green, Sinikka L., additional, Jacobsen, Colleen, additional, Krishnankutty, Jayasree, additional, Phungwayo, Sikhongi, additional, Glover, Richard M., additional, Slechta, Stacy, additional, Holdeman, Troy, additional, Hartvickson, Robyn, additional, Grant, Amber, additional, Poling, Terry L., additional, Klein, Terry D., additional, Klein, Thomas C., additional, Klein, Tracy R., additional, Smith, William B., additional, Gibson, Richard L., additional, Winbigler, Jennifer, additional, Parker, Elizabeth, additional, Wijewardane, Priyantha N., additional, Bravo, Eric, additional, Thessing, Jeffrey, additional, Maxwell, Michelle, additional, Horn, Amanda, additional, Healy, Catherine Mary, additional, Akamine, Christine, additional, Chu, Laurence, additional, Chouteau, R. Michelle, additional, Cotugno, Michael J., additional, Bauer, George H., additional, Hachigian, Greg, additional, Oshita, Masaru, additional, Cancilla, Michael, additional, Kiersey, Kristen, additional, Seger, William, additional, Antwi, Mohammed, additional, Green, Allison, additional, Kim, Anthony, additional, Desjardins, Michael, additional, Johnson, Jennifer A., additional, Sherman, Amy, additional, Borger, Judith, additional, Saleem, Nafisa, additional, Solis, Joel, additional, Medina, Martha Carmen, additional, Keating, Westly, additional, Garcia, Edgar, additional, Bueno, Cynthia, additional, Segall, Nathan, additional, Denham, Douglas S., additional, Weiss, Thomas, additional, Avworo, Ayoade, additional, Hedges, Parke, additional, Strout, Cynthia Becher, additional, Santiago, Rica, additional, Davis, Yvonne, additional, Howenstine, Patty, additional, Bondell, Alison, additional, Marks, Kristin, additional, Wang, Tina, additional, Wilkin, Timothy, additional, Vogler, Mary, additional, Johnston, Carrie, additional, Andrasik, Michele P., additional, Andriesen, Jessica G., additional, Broder, Gail, additional, Eaton, Niles, additional, Gelderblom, Huub G., additional, McClennen, Rachael, additional, Michael, Nelson, additional, Robb, Merlin, additional, Sopher, Carrie, additional, Miller, Vicki E., additional, Santiago, Fredric, additional, Gomez, Blanca, additional, Valika, Insiya, additional, Starr, Amy, additional, Cantos, Valeria D., additional, Kandiah, Sheetal, additional, Rio, Carlos del, additional, Rouphael, Nadine, additional, Edupuganti, Srilatha, additional, Anderson, Evan J., additional, Camacho-Gonzalez, Andres, additional, Kamidani, Satoshi, additional, Teherani, Meghan, additional, Diemert, David J., additional, Malkin, Elissa, additional, Siegel, Marc, additional, Roberts, Afsoon, additional, Simon, Gary, additional, Balani, Bindu, additional, Stephenson, Carolene, additional, Sperber, Steven, additional, Cicogna, Cristina, additional, Zervos, Marcus J., additional, Kilgore, Paul, additional, Ramesh, Mayur, additional, Herc, Erica, additional, Zenlea, Kate, additional, Burgher, Abram, additional, Milliken, Ann M., additional, Davis, Joseph D., additional, Levy, Brendan, additional, Kelman, Sandra, additional, Doust, Matthew W., additional, Sample, Denise, additional, Erickson, Sandra, additional, Christensen, Shane G., additional, Matich, Christopher, additional, Longe, James, additional, Witbeck, John, additional, Peterson, James T., additional, Clark, Alexander, additional, Kelty, Gerald, additional, Pena-Renteria, Issac, additional, Koren, Michael J., additional, Bartilucci, Darlene, additional, Patel, Alpa, additional, Tran, Carolyn, additional, Kennelly, Christina, additional, Brownlee, Robert, additional, Coleman, Jacob, additional, Webster, Hala, additional, Fierro, Carlos A., additional, Leistner, Natalia, additional, Thompson, Amy, additional, Gonzalez, Celia, additional, Jackson, Lisa A., additional, Suyehira, Janice, additional, Haber, Milton, additional, Regalado, Maria M., additional, Procasky, Veronica, additional, Lutat, Alisha, additional, Griffin, Carl P., additional, Hollister, Ripley R., additional, Brown, Jeremy, additional, Ronk, Melody, additional, Harper, Wayne L., additional, Cohen, Lisa, additional, Eckert, Lynn, additional, Hong, Matthew, additional, Rouhbakhsh, Rambod, additional, Danford, Elizabeth, additional, Johnson, John, additional, Calderone, Richard, additional, Khetan, Shishir K., additional, Olanrewaju, Oyebisi, additional, Zhai, Nan, additional, Nieves, Kimberly, additional, O'Brien, Allison, additional, Bradley, Paul S., additional, Lilienthal, Amanda, additional, Callis, Jim, additional, Brosz, Adam B., additional, Clement, Andrea, additional, West, Whitney, additional, Friesen, Luke, additional, Cramer, Paul, additional, Eder, Frank S., additional, Little, Ryan, additional, Engler, Victoria, additional, Rattenbury-Shaw, Heather, additional, Ensz, David J., additional, Oplinger, Allie, additional, Essink, Brandon J., additional, Meyer, Jay, additional, Raiser, Frederick, additional, Mueller, Kimberly, additional, Vrbicky, Keith W., additional, Harper, Charles, additional, Nutsch, Chelsie, additional, Lewis, Wendell, additional, Laflan, Cathy, additional, Whatley, Jordan L., additional, Harrell, Nicole, additional, Shannon, Amie, additional, Rowell, Crystal, additional, Dedon, Christopher, additional, Makhene, Mamodikoe, additional, Gottschlich, Gregory M., additional, Harden, Kate, additional, Gottschlich, Melissa, additional, Smith, Mary, additional, Powell, Richard, additional, Kimmel, Murray A., additional, Pinto, Simmy, additional, Vachris, Timothy P., additional, Hutchens, Mark, additional, Daniels, Stephen, additional, Wells, Margaret, additional, Van Der Leden, Mimi, additional, Jackson-Booth, Peta-Gay, additional, Baron, Mira, additional, Kane, Pamela, additional, Seversen, Shannen, additional, Kryvicky, Mara, additional, Lord, Julia, additional, Saleh, Jamshid, additional, Miles, Matthew, additional, Lupercio, Rafael, additional, McGettigan, John W., additional, Patton, Walter, additional, Brakema, Riemke, additional, Choquette, Karin, additional, McGettigan, Jonlyn, additional, Kirstein, Judith L., additional, Bernard, Marcia, additional, Manning, Mary Beth, additional, Rothenberg, Joan, additional, Briskin, Toby, additional, Roadman, Denise, additional, Tedder-Edwards, Sharita, additional, Schwartz, Howard I., additional, Mederos, Surisday, additional, Swaminathan, Shobha, additional, Nyaku, Amesika, additional, Varughese, Tilly, additional, DallaPiazza, Michelle, additional, Frey, Sharon E., additional, Graham, Irene, additional, Abate, Getahun, additional, Hoft, Daniel, additional, Allen, Leland N., additional, Edwards, Leslie A., additional, Davis, William S., additional, Mena, Jessica M., additional, Kutner, Mark E., additional, Caso, Jorge, additional, Moran, Maria Hernandez, additional, Carvajal, Marianela, additional, Mendez, Janet, additional, Wadsworth, Larkin T., additional, Adams, Michael R., additional, Iverson, Leslie, additional, Newberg, Joseph L., additional, Pearlman, Laura, additional, Nugent, Paul J., additional, Reynolds, Michele D., additional, Bashour, Jennifer, additional, Schmidt, Robert, additional, Sheth, Neil P., additional, Steil, Kenneth, additional, Toma, Ramy J., additional, Kirby, William, additional, Folmar, Pink, additional, Williams, Samantha, additional, Pickrell, Paul, additional, Mott, Stefanie, additional, Linebarger, Carol Ann, additional, Malbari, Hussain, additional, Pampe, David, additional, Fragoso, Veronica G., additional, Holloway, Lisa, additional, McKeown-Bragas, Cecilia, additional, Becker, Teresa, additional, Williams, Barton G., additional, Jones, William H., additional, Clark, Jesse L., additional, Shoptaw, Steven, additional, Vertucci, Michele, additional, Hernandez, Will, additional, Spector, Stephen A., additional, Moodley, Amaran, additional, Blumenthal, Jill, additional, Stangl, Lisa, additional, Deutsch, Karen, additional, Mullane, Kathleen M., additional, Pitrak, David, additional, Nuss, Cheryl, additional, Pi, Judy, additional, Fichtenbaum, Carl, additional, Powers-Fletcher, Margaret, additional, Saemann, Michelle, additional, Kohrs, Sharon, additional, Campbell, Thomas B., additional, Lauria, Andrew, additional, Mancilla, Jose C., additional, Dunlevy, Hillary, additional, Novak, Richard M., additional, Wendrow, Andrea, additional, Borgetti, Scott, additional, Ladner, Ben, additional, Chrisley, Lisa, additional, Young, Cheryl, additional, Doblecki-Lewis, Susanne, additional, Alcaide, Maria L., additional, Gonzales-Zamora, Jose, additional, Morris, Stephen, additional, Wohl, David, additional, Eron, Joseph, additional, Frank, Ian, additional, Dunbar, Debora, additional, Metzger, David, additional, Momplaisir, Florence, additional, Martin, Judith, additional, Hoberman, Alejandro, additional, Shope, Timothy, additional, Muniz, Gysella, additional, Rupp, Richard, additional, Stanford, Amber, additional, Berman, Megan, additional, Porterfield, Laura, additional, Lewis, Michael, additional, Ghadishah, Elham, additional, Yusin, Joseph, additional, Pham, Mai, additional, Creech, Clarence B., additional, Walker, Shannon, additional, Rolsma, Stephanie, additional, Samuels, Robert, additional, Thomsen, Isaac, additional, Kalams, Spyros A., additional, Wilson, Greg, additional, Lucksinger, Gregg H., additional, Parks, Kevin, additional, Israelsen, Ryan, additional, Ostovar, Jaleh, additional, Kelly, Kary, additional, Overcash, Jeffrey S., additional, Chu, Hanh, additional, Lee, Kia, additional, De La Cruz, Luis I., additional, Clemons, Steve, additional, Everette, Elizabeth, additional, Studdard, Suzanna, additional, Mohan, Gowdhami, additional, Tyson, Stefanie, additional, Peay, Alyssa-Kay, additional, Johnson, Danyel, additional, Feldman, Gregory J., additional, Suen, May-Yin, additional, Muenzner, Jacqueline, additional, Boscia, Joseph, additional, Siddiqui, Farhan, additional, Sanders, John, additional, Peacock, James, additional, Nasim, Julio, additional, Levin, Michael L., additional, Hussey, Julie, additional, Kulic, Marcy, additional, McKenzie, Mark M., additional, Deese, Teresa, additional, Osmundsen, Erica, additional, Sweet, Christy, additional, Ebuh, Valentine M., additional, Elnagar, Elwaleed, additional, Ebuh, Georgette, additional, Iwuala, Genevieve, additional, Han-Conrad, Laurie J., additional, Simmons, Todd, additional, Tarakjian, Denis, additional, Ackermann, Jeremy, additional, Adams, Mark S., additional, Alemán, José O., additional, Al-Ibrahim, Mohamed S., additional, Andes, David R., additional, Andrews, Jeb, additional, Arduino, Roberto C., additional, Bäcker, Martín, additional, Badillo, Diana, additional, Bainbridge, Emma, additional, Batteiger, Teresa A., additional, Bazan, Jose A., additional, Bedimo, Roger J., additional, Benitez, Jorge A., additional, Bennett, Annette R., additional, Bernstein, David I., additional, Bialobok, Kristin, additional, Boas, Rebecca, additional, Brady, Judith, additional, Brown, Cynthia, additional, Bunce, Catherine A., additional, Call, Robert S., additional, Campbell, Wesley, additional, Carmody, Ellie, additional, Carpenter, Christopher, additional, Carsons, Steven E., additional, Castellon, Marvin, additional, Castro, Mario, additional, Catan, Hannah, additional, Chang, Jennifer, additional, Chebib, Mouna G., additional, Chen, Corey M., additional, Cheng, Margaret, additional, Chow, Brian D.W., additional, Ciambruschini, Annie, additional, Connor, Joseph P., additional, Conway, James H., additional, Cooney, Maureen, additional, Curlin, Marcel, additional, De La Matta Rodriguez, Claudia, additional, Dedon, Jon F., additional, Degan, Emily, additional, Dickey, Michelle, additional, Dietz, Craig, additional, Dong, Jennifer L., additional, Dorcely, Brenda, additional, Dube, Michael P., additional, Dyer, Carmel B., additional, Eckhardt, Benjamin, additional, Ellerbeck, Edward, additional, Ewers, Evan C., additional, Falk, Amy, additional, Feijoo, Brittany, additional, Felsen, Uriel R., additional, Fiel, Tom, additional, Fitz-Patrick, David, additional, Fogarty, Charles M., additional, Ford, Stacy, additional, Forero, Lina M., additional, Formentini, Elizabeth, additional, Franco-Vitteri, Doris, additional, Frenck, Robert W., additional, Gharib, Elie, additional, Gharib, Suzanne, additional, Rucker, Rola G., additional, Goldenberg, James N., additional, González, Luis H., additional, Gray, Brett, additional, Greene, Rusty, additional, Grossberg, Robert M., additional, Guanira-Carranza, Juan V., additional, Guerreros Benavides, Alfredo Gilberto, additional, Guillory, Clint C., additional, Gunaratne, Shauna H., additional, Halpert, David, additional, Hamilton, Holli, additional, Hartman, William R., additional, Henderson, Sheryl L., additional, Herati, Ramin, additional, Guarin, Laura Hernandez, additional, Hilder, Robin, additional, Ho, Ken, additional, Hojat, Leila, additional, Hosek, Sybil G., additional, Jacobson, Jeffrey M., additional, Jay, Melanie, additional, Johnson, Diane H., additional, Jones, Kathleen S., additional, Jones-López, Edward C., additional, Justman, Jessica E., additional, Kahney, Scott, additional, Katz, Lois, additional, Katz, Melinda, additional, Kaul, Daniel, additional, Keefer, Michael C., additional, Kennedy, Ashley, additional, Knishinsky, Jennifer, additional, Kogelman, Laura, additional, Koletar, Susan L., additional, Kottkamp, Angelica, additional, Laguio-Vila, Maryrose, additional, Landovitz, Raphael J., additional, Lee, Jessica L., additional, Liu, Albert, additional, Llerena Zegarra, Eneyda Giuvanela, additional, Lok, Anna S., additional, Lovell, James, additional, Lubelchek, Ronald, additional, Lucaj, John, additional, Luckasen, Gary, additional, Luetkemeyer, Annie, additional, Lugogo, Njira Lucia, additional, Maenza, Janine, additional, Malvestutto, Carlos, additional, Mauri, Monica, additional, Maves, Ryan C., additional, Mayer, Kenneth H., additional, McCartney, Michael J., additional, McCort, Margaret E., additional, McElrath, M. Juliana, additional, McNairy, Meredith, additional, Merino, Fernando L., additional, Meyerowitz, Eric A., additional, Mitchell, Carol L., additional, Monaco, Cynthia L., additional, Muhammad, Sauda, additional, Muñoz-Gómez, Sigridh, additional, Munsiff, Sonal, additional, Nee, Paul, additional, Nollen, Nicole L., additional, Noor, Asif, additional, Lagos, Claudio Nuñez, additional, Okulicz, Jason F., additional, Oliver, Patrick A., additional, Ortega, Jessica, additional, Palmer, Steven, additional, Parameswaran, Lalitha, additional, Parikh, Purvi, additional, Parker, Susan, additional, Parungao, Reza, additional, Pavie, Juana R., additional, Madan, Rebecca P., additional, Peralta, Henry, additional, Petts, Jennifer, additional, Pierce, Kristen K., additional, Pretell Alva, E. Javier, additional, Purpura, Lawrence J., additional, Raabe, Vanessa, additional, Recuenco, Sergio E., additional, Richards, Tamara, additional, Riddler, Sharon A., additional, Rizzardi, Barbara, additional, Rokser, Rachel, additional, Rolle, Charlotte-Paige, additional, Rosen, Adam, additional, Rosen, Jeffrey, additional, Freese, Lena R., additional, Santolaya, María E., additional, Schipani, Linda M., additional, Schwartz, Adam, additional, Schwasinger-Schmidt, Tiffany, additional, Scott, Hyman, additional, Sha, Beverly E., additional, Shankaran, Shivanjali, additional, Shapiro, Adrienne E., additional, Sharp, Stephan C., additional, Shopsin, Bo, additional, Sims, Matthew D., additional, Skipper, Stephanie, additional, Smith, Derek M., additional, Smith, Michael J., additional, Sobhanie, M. Mahdee, additional, Sovic, Brit, additional, Sterling, Stephanie, additional, Striker, Robert, additional, Tafur Bances, Karla Beatriz, additional, Talaat, Kawsar R., additional, Tavel, Edward M., additional, Tieu, Hong V., additional, Tomaszewski, Christian, additional, Tomlinson, Ryan, additional, Torres, Juan P., additional, Torres, Julian A., additional, Treanor, John J., additional, Tukuru, Sade, additional, Ulrich, Robert J., additional, Utz, Gregory C., additional, Viar, Veronica, additional, Viau Colindres, Roberto A., additional, Walsh, Edward E., additional, Walsh, Mary C., additional, Walter, Emmanuel B., additional, Weidler, Jessica L., additional, Wu, Yi H., additional, Yang, Kinara S., additional, Yrivarren Giorza, Juan Luis, additional, Zemanek, Arthur L., additional, Zhang, Kevin, additional, Zingman, Barry S., additional, Gorman, Richard, additional, Paez, Carmen A., additional, Swann, Edith, additional, Takuva, Simbarashe G., additional, Greninger, Alex, additional, Roychoudhury, Pavitra, additional, Coombs, Robert W., additional, Jerome, Keith R., additional, Castellino, Flora, additional, Tong, Xiaomi, additional, Pavetto, Corrina, additional, Gipson, Teletha, additional, Tong, Tina, additional, Lee, Marina, additional, Zhou, James, additional, Fay, Michael, additional, McQuarrie, Kelly, additional, Nnadi, Chimeremma, additional, Sogbetun, Obiageli, additional, Ahmad, Nina, additional, De Proost, Ian, additional, Hoseyni, Cyrus, additional, Coplan, Paul, additional, Khan, Najat, additional, Ronco, Peter, additional, Furey, Dawn, additional, Meck, Jodi, additional, Vingerhoets, Johan, additional, Brandenburg, Boerries, additional, Custers, Jerome, additional, Hendriks, Jenny, additional, Juraszek, Jarek, additional, Marit de Groot, Anne, additional, Van Roey, Griet, additional, Heerwegh, Dirk, additional, Van Dromme, Ilse, additional, Méndez Galván, Jorge F., additional, Carrascal, Monica B., additional, Duran, Adriana Sordo, additional, Sanchez Guerrero, Laura Ruy, additional, Gómora Madrid, Martha Cecilia, additional, Barrat Hernández, Alejandro Quintín, additional, Guizar, Sharzhaad Molina, additional, González Estrada, Denisse Alejandra, additional, Martínez Pérez, Silvano Omar, additional, Zárate Hinojosa, Zindy Yazmín, additional, Ruiz-Palacios, Guillermo Miguel, additional, Cruz-Valdez, Aurelio, additional, Pacheco-Flores, Janeth, additional, Lara, Anyela, additional, Díaz-Miralrio, Secia, additional, Reyes Fentanes, María José, additional, Olmos Vega, Jocelyn Zuleica, additional, Méndez, Daniela Pineda, additional, Martínez, Karina Cano, additional, Alvarez León, Winniberg Stephany, additional, Ruiz Herrera, Vida Veronica, additional, Vázquez Saldaña, Eduardo Gabriel, additional, Camacho Choza, Laura Julia, additional, Vega Orozco, Karen Sofia, additional, Ortega Domínguez, Sandra Janeth, additional, Chacón, Jorge A., additional, Rivera, Juan J., additional, Cutz, Erika A., additional, Ortegón, Maricruz E., additional, Rivera, María I., additional, Browder, David, additional, Burch, Cortney, additional, Moye, Terri, additional, Bondy, Paul, additional, Browder, Lesley, additional, Manning, Rickey D., additional, Hurst, James W., additional, Sturgeon, Rodney E., additional, Wakefield, Paul H., additional, Kirby, John A., additional, Andersen, James, additional, Fearon, Szheckera, additional, Negron, Rosa, additional, Medina, Amy, additional, Hill, John M., additional, Rajasekhar, Vivek, additional, Williams, Hayes, additional, Cade, LaShondra, additional, Fouts, Rhodna, additional, Moya, Connie, additional, Anderson, Corey G., additional, Devine, Naomi, additional, Ramsey, James, additional, Perez, Ashley, additional, Tatelbaum, David, additional, Jacobs, Michael, additional, Menasche, Kathleen, additional, Mirkil, Vincent, additional, Winkle, Peter J., additional, Haggag, Amina Z., additional, Haynes, Michelle, additional, Villegas, Marysol, additional, Raja, Sabina, additional, Riesenberg, Robert, additional, Plavin, Stanford, additional, Lerman, Mark, additional, Woodside, Leana, additional, Johnson, Maria, additional, Healy, C. Mary, additional, Whitaker, Jennifer A., additional, Keitel, Wendy A., additional, Atmar, Robert L., additional, Horwith, Gary, additional, Mason, Robin, additional, Johnson, Lisa, additional, Dora, Tambra, additional, Murray, Deborah, additional, Ledbetter, Logan, additional, Ewing, Beverly, additional, Stephenson, Kathryn E., additional, Tan, Chen S., additional, Zash, Rebecca, additional, Ansel, Jessica L., additional, Jaegle, Kate, additional, Guiney, Caitlin J., additional, Henderson, Jeffrey A., additional, O'Leary, Marcia, additional, Enright, Kendra, additional, Kessler, Jill, additional, Ducheneaux, Pete, additional, Inniss, Asha, additional, Brandon, Donald M., additional, Davis, William B., additional, Lawler, Daniel T., additional, Oppong, Yaa D., additional, Starr, Ryan P., additional, Syndergaard, Scott N., additional, Shelly, Rozeli, additional, Majumder, Mashrur Islam, additional, Sugimoto, Danny, additional, Dugas, Jeffrey, additional, Rijos, Dolores, additional, Shelton, Sandra, additional, Hong, Stephan, additional, Schwartz, Howard, additional, Sanchez-Crespo, Nelia, additional, Schwartz, Jennifer, additional, Piedra, Terry, additional, Corral, Barbara, additional, Medina, Carmen, additional, Dever, Michael E., additional, Shah, Mitul, additional, Delgado, Michael, additional, Scott, Tameika, additional, Usdan, Lisa S., additional, McGill, Lora J., additional, Arnold, Valerie K., additional, Scatamacchia, Carolyn, additional, Anthony, Codi M., additional, Merchant, Rajan, additional, Yoon, Anelgine C., additional, Hill, Janet, additional, Ng-Price, Lucy, additional, Thompson-Seim, Teri, additional, Ackerman, Ronald, additional, Ackerman, Jamie, additional, Aristy, Florida, additional, Ketter, Nzeera, additional, Finley, Jon, additional, Stull, Mildred, additional, Murray, Monica, additional, Rizvi, Zainab, additional, Guerrero, Sonia, additional, Paliwal, Yogesh K., additional, Paliwal, Amit, additional, Gordon, Sarah, additional, Gordon, Bryan, additional, Montano-Pereira, Cynthia, additional, Galloway, Christopher, additional, Montros, Candice, additional, Aleman, Lily, additional, Shairi, Samira, additional, Van Ever, Wesley, additional, Freeman, George H., additional, Harmon, Esther L., additional, Cross, Marshall A., additional, Sales, Kacie, additional, Gular, Catherine Q., additional, Hepburn, Matthew, additional, Alderson, Nathan, additional, Harshell, Shana, additional, Mahgoub, Siham, additional, Maxwell, Celia, additional, Mellman, Thomas, additional, Thompson, Karl M., additional, Wortman, Glenn, additional, Kingsley, Jeff, additional, Pixler, April, additional, Curry, LaKondria, additional, Afework, Sarah, additional, Swanson, Austin, additional, Jacqmein, Jeffry, additional, Bowers, Maggie, additional, Robison, Dawn, additional, Mosteller, Victoria, additional, Garvey, Janet, additional, Easley, Mary, additional, Kurnat, Rebecca J., additional, Cornelison, Raymond, additional, Gower, Shanda, additional, Schnitz, William, additional, Heinzig-Cartwright, Destiny S., additional, Lewis, Derek, additional, Newton, Fred E., additional, Duhart, Aeiress, additional, Watkins, Breanz, additional, Ball, Brandy, additional, York, Jill, additional, Pickle, Shelby, additional, Musante, David B., additional, Silver, William P., additional, Belhorn, Linda R., additional, Viens, Nicholas A., additional, Dellaero, David, additional, Patel, Priti, additional, Lisec, Kendra, additional, Safirstein, Beth, additional, Zapata, Luz, additional, Gonzalez, Lazaro, additional, Quevedo, Evelyn, additional, Irani, Farah, additional, Grillo, Joseph, additional, Potts, Amy, additional, White, Julie, additional, Flume, Patrick, additional, Headden, Gary, additional, Taylor, Brandie, additional, Warden, Ashley, additional, Chamberlain, Amy, additional, Jeanfreau, Robert, additional, Jeanfreau, Susan, additional, Matherne, Paul G., additional, Caldwell, Amy, additional, Stahl, Jessica, additional, Vowell, Mandy, additional, Newhouse, Lauren, additional, Berthaud, Vladimir, additional, Takizala, Zudi-Mwak, additional, Beninati, Genevieve, additional, Snell, Kimberly, additional, Baker, Sherrie, additional, Walker, James, additional, Harrison, Tavane, additional, Miller, Meagan, additional, Otto, Janet, additional, Gray, Roni, additional, Wilson, Christine, additional, Nemecek, Tiffany, additional, Harrington, Hannah, additional, Eppenbach, Sally, additional, Bourgeois, Tana, additional, Folsom, Lyndsea, additional, Holt, Gregory, additional, Mirsaeidi, Mehdi, additional, Calderon, Rafael, additional, Lichtenberger, Paola, additional, Quintero, Jalima, additional, Martinez, Becky, additional, Immergluck, Lilly, additional, Johnson, Erica, additional, Chan, Austin, additional, Fas, Norberto, additional, Thomas-Seaton, LaTeshia, additional, Khizer, Saadia, additional, Staben, Jonathan, additional, Beresnev, Tatiana, additional, Jahromi, Maryam, additional, Marovich, Mary A., additional, Hutter, Julia, additional, Nason, Martha, additional, Ledgerwood, Julie, additional, Mascola, John, additional, Leibowitz, Mark, additional, Morales, Fernanda, additional, Delgado, Mike, additional, Sanchez, Rosario, additional, Vega, Norma, additional, Áñez, Germán, additional, Albert, Gary, additional, Coston, Erin, additional, Desai, Chinar, additional, Dunbar, Haoua, additional, Eickhoff, Mark, additional, Garcia, Jenina, additional, Kautz, Margaret, additional, Lee, Angela, additional, Lewis, Maggie, additional, McGarry, Alice, additional, McKnight, Irene, additional, Nelson, Joy, additional, Newingham, Patrick, additional, Price-Abbott, Patty, additional, Reed, Patty, additional, Vegas, Diana, additional, Wilkinson, Bethanie, additional, Smith, Katherine, additional, Woo, Wayne, additional, Cho, Iksung, additional, Glenn, Gregory M., additional, Dubovsky, Filip, additional, Fried, David L., additional, Haughey, Lynne A., additional, Stanton, Ariana C., additional, Rameaka, Lisa Stevens, additional, Rosenberg, David, additional, Tomatsu, Lee, additional, Gonzalez, Viviana, additional, Manalo, Millie, additional, Grunstra, Bernard, additional, Quinn, Donald, additional, Claybrook, Phillip, additional, Olds, Shelby, additional, Dye, Amy, additional, Cannon, Kevin D., additional, Chadwick, Mesha M., additional, Jordan, Bailey, additional, Hussey, Morgan, additional, Nevarez, Hannah, additional, Kelley, Colleen F., additional, Chung, Michael, additional, Moran, Caitlin, additional, Rebolledo, Paulina, additional, Bacher, Christina, additional, Barranco-Santana, Elizabeth, additional, Rodriguez, Jessica, additional, Mendoza, Rafael, additional, Ruperto, Karen, additional, Olivieri, Odette, additional, Ocaña, Enrique, additional, Wylie, Paul E., additional, Henderson, Renea, additional, Jenson, Natasa, additional, Yang, Fan, additional, Kelley, Amy, additional, Finkelstein, Kenneth, additional, Beckmann, David, additional, Hutchins, Tanya, additional, Escallon, Sebastian Garcia, additional, Johnson, Kristen, additional, Sligh, Teresa S., additional, Desai, Parul, additional, Huynh, Vincent, additional, Lopez, Carlos, additional, Mendoza, Erika, additional, Adelglass, Jeffrey, additional, Naifeh, Jerome G., additional, Kucera, Kristine J., additional, Chughtai, Waseem, additional, Jaffer, Shireen H., additional, Davis, Matthew G., additional, Foley, Jennifer, additional, Burgett, Michelle L., additional, Shlotzhauer, Tammi L., additional, Ingalsbe-Geno, Sarah M., additional, Duncanson, Daniel, additional, Kush, Kelly, additional, Nesbitt, Lori, additional, Sonnier, Cora, additional, McCarter, Jennifer, additional, Butcher, Michael B., additional, Fry, James, additional, Percy, Donna, additional, Freudemann, Karen, additional, Gebhardt, Bruce C., additional, Mangu, Padma N., additional, Schroeck, Debra B., additional, Davit, Rajesh K., additional, Hennekes, Gayle D., additional, Luft, Benjamin J., additional, Carr, Melissa, additional, Nachman, Sharon, additional, Pellecchia, Alison, additional, Smith, Candace, additional, Valenti, Bruno, additional, Bermudez, Maria I., additional, Peraita, Noris, additional, Delgado, Ernesto, additional, Arrazcaeta, Alicia, additional, Ramirez, Natalie, additional, Amador, Carmen, additional, Marafioti, Horacio, additional, Dang, Lyly, additional, Clement, Lauren, additional, Berry, Jennifer, additional, Allaw, Mohammed, additional, Geuss, Georgettea, additional, Miles, Chelsea, additional, Bittner, Zachary, additional, Werne, Melody, additional, Calinescu, Cornell, additional, Rodman, Shannon, additional, Rindt, Joshua, additional, Cooksey, Erin, additional, Harrison, Kristina, additional, Cooper, Deanna, additional, Horton, Manisha, additional, Philyaw, Amanda, additional, Jennings, William, additional, Alvarado, Hilario, additional, Baka, Michele, additional, Regalado, Malina, additional, Murray, Linda, additional, Naguib, Sherif, additional, Singletary, Justin, additional, Richmond, Sha-Wanda, additional, Omodele, Sarah, additional, Oppenheim, Emily, additional, Martinez, Reuben, additional, Andriulis, Victoria, additional, Singer, Leonard, additional, Blevins, Jeanne, additional, Thomas, Meagan, additional, Hull, Christine, additional, Pereira, Isabel, additional, Rivero, Gina, additional, Okonya, Tracy, additional, Downing, Frances, additional, Miller, Paulina, additional, Rhee, Margaret, additional, Stapleton, Katherine, additional, Klein, Jeffrey, additional, Hong, Rosamond, additional, Swan, Suzanne, additional, Wahlin, Tami, additional, Bennett, Elizabeth, additional, Salzl, Amy, additional, Phan, Sharine, additional, White, Jewel J., additional, Occhino, Amanda, additional, Paiano, Ruth, additional, McLaughlin, Morgan, additional, Swieboda, Elisa, additional, Garcia-Fragoso, Veronica, additional, Becerra, Maria G., additional, White, Toni, additional, Turley, Christine B., additional, McWilliams, Andrew, additional, Esinhart, Tiffany, additional, Montoya, Natasha, additional, Huskey, Shamika, additional, Paul, Leena, additional, Tashima, Karen, additional, Johnson, Jennie, additional, Neill, Marguerite, additional, Sanchez, Martha, additional, Rybak, Natasha, additional, Mileno, Maria, additional, Cohen, Stuart H., additional, Ruiz, Monica, additional, Boswell, Dean M., additional, Robison, Elizabeth E., additional, Reynolds, Trina L., additional, Neumeister, Sonja, additional, Zorrilla, Carmen D., additional, Rivera, Juana, additional, Ibarra, Jessica, additional, García, Iris, additional, Sierra, Dianca, additional, Ramon, Wanda, additional, Fiorillo, Suzanne, additional, Pitotti, Rebecca, additional, Anderson, Victoria R., additional, Mancilla, Jose Castillo, additional, Le, Nga, additional, Winokur, Patricia L., additional, Ince, Dilek, additional, Hegmann, Theresa, additional, Meier, Jeffrey, additional, Stapleton, Jack, additional, Stulken, Laura, additional, McArthur, Monica, additional, Berry, Andrea, additional, Tapia, Milagritos, additional, Hammershaimb, Elizabeth, additional, Robinson, Toni, additional, MacBryde, Rosa, additional, Kline, Susan, additional, Billings, Joanne L., additional, Cavert, Winston, additional, Forgosh, Les B., additional, Schacker, Timothy W., additional, Bold, Tyler D., additional, Dandachi, Dima, additional, Nelson, Taylor, additional, Bran, Andres, additional, Geiger, Grant, additional, Naqvi, S. Hasan, additional, Florescu, Diana F., additional, Starlin, Richard, additional, Kline, David, additional, Zimmer, Andrea, additional, Abbas, Anum, additional, Wilson, Natasha, additional, Eron, Joseph J., additional, Sciaudone, Michael, additional, Rosengren, A. Lina, additional, Kizer, John S., additional, Rutstein, Sarah E., additional, Bruce, Elizabeth, additional, Espinosa, Claudia, additional, Sanders, Lisa J., additional, Kim, Kami, additional, Casey, Denise, additional, Taylor, Barbara S., additional, Patterson, Thomas, additional, Pinilla, Ruth S., additional, Bullock, Delia, additional, Ponce, Philip, additional, Patterson, Jan, additional, McClelland, R. Scott, additional, Lane, Dakotah C., additional, Wald, Anna, additional, James, Frank, additional, Duke, Elizabeth, additional, Hauge, Kirsten, additional, Heimonen, Jessica, additional, Goecker, Erin A., additional, Fong, Youyi, additional, Kauffman, Carol, additional, Linder, Kathleen, additional, Nofz, Kimberly, additional, McConnell, Andrew, additional, Buynak, Robert J., additional, Webb, Angella, additional, Petty, Taryn, additional, Andree, Stephanie, additional, Sanchez, Erica, additional, Mackey, Nolan, additional, Baudelaire, Clarisse, additional, Dzigiel, Sarah, additional, Marquez, Adrienna, additional, Quillin, Kim, additional, King, Michelle, additional, Abad, Vanessa, additional, Knowles, Jennifer, additional, Waters, Michael, additional, Zepeda, Karla, additional, Coslet, Jordan, additional, Tovar, Dalia, additional, Shaw, Marian E., additional, Turner, Mark A., additional, Huffine, Cory J., additional, Huffine, Esther S., additional, Ake, Julie A., additional, Secord, Elizabeth, additional, McGrath, Eric, additional, Levy, Phillip, additional, Stewart, Brittany, additional, Cromer, Charnell, additional, Walters, Ayanna, additional, Ellsworth, Grant, additional, Greene, Caroline, additional, Galloway, Sarah, additional, Kapadia, Shashi, additional, DeHaan, Elliot, additional, Wilson, Clint, additional, Milligan, Jason, additional, Raley, Danielle, additional, Bocchini, Joseph, additional, McClenathan, Bruce, additional, Hussain, Mary, additional, Lomasney, Evelyn, additional, Hall, Evelyn, additional, Lamberth, Sherry, additional, Schmeck, Christy, additional, Leathers, Vickie, additional, Theodore, Deborah A., additional, Branche, Angela R., additional, Graciaa, Daniel S., additional, Hatlen, Timothy J., additional, Miller, Jacqueline, additional, Sadoff, Jerald, additional, Falsey, Ann R., additional, and Sobieszczyk, Magdalena E., additional

Published
2023
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45. Safety, Tolerability, and Immunogenicity of Repeated Doses of DermaVir, a Candidate Therapeutic HIV Vaccine, in HIV-Infected Patients Receiving Combination Antiretroviral Therapy

Author

Rodriguez, Benigno, Asmuth, David M, Matining, Roy M, Spritzler, John, Jacobson, Jeffrey M, Mailliard, Robbie B, Li, Xiao-Dong, Martinez, Ana I, Tenorio, Allan R, Lori, Franco, Lisziewicz, Julianna, Yesmin, Suria, Rinaldo, Charles R, and Pollard, Richard B

Subjects
Clinical Research, Clinical Trials and Supportive Activities, Infectious Diseases, HIV/AIDS, Immunization, Vaccine Related, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Infection, Good Health and Well Being, AIDS Vaccines, Anti-HIV Agents, CD4 Lymphocyte Count, CD4-Positive T-Lymphocytes, CD8-Positive T-Lymphocytes, Drug Therapy, Combination, Humans, Immunization Schedule, RNA, Viral, Viral Load, Viremia, DermaVir, CTL responses, HIV therapeutic vaccines, HIV-specific immune responses, Clinical Sciences, Public Health and Health Services, Virology
Abstract

BackgroundHIV-specific cellular immune responses are associated with control of viremia and delayed disease progression. An effective therapeutic vaccine could mimic these effects and reduce the need for continued antiretroviral therapy. DermaVir, a topically administered plasmid DNA-nanomedicine expressing HIV (CladeB) virus-like particles consisting of 15 antigens, induces predominantly central memory T-cell responses.MethodsTreated HIV-infected adults (HIV RNA 350) were randomized to placebo or escalating DermaVir doses (0.1 or 0.4 mg of plasmid DNA at weeks 1, 7, and 13 in the low- and intermediate-dose groups and 0.8 mg at weeks 0, 1, 6, 7, 12, and 13 in the high-dose group), n = 5-6 evaluable subjects per group. Immunogenicity was assessed by a 12-day cultured interferon-γ enzyme-linked immunosorbent spot assay at baseline and at weeks 9, 17, and 37 using 1 Tat/Rev and 3 overlapping Gag peptide pools (p17, p24, and p15).ResultsGroups were comparable at baseline. The study intervention was well tolerated, without dose-limiting toxicities. Most responses were highest at week 17 (4 weeks after last vaccination) when Gag p24 responses were significantly greater among intermediate-dose group compared with control subjects [median (IQR): 67,600 (5633-74,368) versus 1194 (9-1667)] net spot-forming units per million cells, P = 0.032. In the intermediate-dose group, there was also a marginal Gag p15 response increase from baseline to week 17 [2859 (1867-56,933), P = 0.06], and this change was significantly greater than in the placebo group [0 (-713 to 297), P = 0.016].ConclusionsDermaVir administration was associated with a trend toward greater HIV-specific, predominantly central memory T-cell responses. The intermediate DermaVir dose tended to show the greatest immunogenicity, consistent with previous studies in different HIV-infected patient populations.

Published
2013

46. Pegylated Interferon Alfa-2a Monotherapy Results in Suppression of HIV Type 1 Replication and Decreased Cell-Associated HIV DNA Integration

Author

Azzoni, Livio, Foulkes, Andrea S, Papasavvas, Emmanouil, Mexas, Angela M, Lynn, Kenneth M, Mounzer, Karam, Tebas, Pablo, Jacobson, Jeffrey M, Frank, Ian, Busch, Michael P, Deeks, Steven G, Carrington, Mary, O'Doherty, Una, Kostman, Jay, and Montaner, Luis J

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Immunology, Sexually Transmitted Infections, Infectious Diseases, Clinical Trials and Supportive Activities, Clinical Research, HIV/AIDS, Infection, Adult, Antiviral Agents, Female, HIV Infections, HIV-1, Humans, Immunotherapy, Interferon-alpha, Male, Middle Aged, Polyethylene Glycols, Recombinant Proteins, Treatment Outcome, Virus Integration, Virus Replication, interferon-alpha, viral integration, immunotherapy, Biological Sciences, Medical and Health Sciences, Microbiology, Biological sciences, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundAntiretroviral therapy (ART)-mediated immune reconstitution fails to restore the capacity of the immune system to spontaneously control human immunodeficiency virus (HIV) replication.MethodsA total of 23 HIV type 1 (HIV-1)-infected, virologically suppressed subjects receiving ART (CD4(+) T-cell count, >450 cells/μL) were randomly assigned to have 180 μg/week (for arm A) or 90 μg/week (for arm B) of pegylated (Peg) interferon alfa-2a added to their current ART regimen. After 5 weeks, ART was interrupted, and Peg-interferon alfa-2a was continued for up to 12 weeks (the primary end point), with an option to continue to 24 weeks. End points included virologic failure (viral load, ≥ 400 copies/mL) and adverse events. Residual viral load and HIV-1 DNA integration were also assessed.ResultsAt week 12 of Peg-interferon alfa-2a monotherapy, viral suppression was observed in 9 of 20 subjects (45%), a significantly greater proportion than expected (arm A, P = .0088; arm B, P = .0010; combined arms, P < .0001). Over 24 weeks, both arms had lower proportions of subjects who had viral load, compared with the proportion of subjects in a historical control group (arm A, P = .0046; arm B, P = .0011). Subjects who had a sustained viral load of

Published
2013

48. African American/Black race, apolipoprotein L1, and serum creatinine among persons with HIV

Author

Shelton, Brittany A., primary, Sawinski, Deirdre, additional, Peter, Inga, additional, Maclennan, Paul A., additional, Pelletier, Nicole F., additional, Nadkarni, Girish, additional, Julian, Bruce, additional, Saag, Michael, additional, Fatima, Huma, additional, Crane, Heidi, additional, Lee, Wonjun, additional, Moore, Richard D., additional, Christopoulos, Katerina, additional, Jacobson, Jeffrey M., additional, Eron, Joseph J., additional, Kumar, Vineeta, additional, and Locke, Jayme E., additional

Published
2023
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50. Risk Stratification of Advanced Fibrosis in Patients With Human Immunodeficiency Virus and Hepatic Steatosis Using the Fibrosis-4, Nonalcoholic Fatty Liver Disease Fibrosis, and BARD Scores.

Author

Yendewa, George A, Khazan, Ana, and Jacobson, Jeffrey M

Subjects
NON-alcoholic fatty liver disease, HEPATIC fibrosis, FATTY liver, HIV, FIBROSIS
Abstract

Background Nonalcoholic fatty liver disease (NAFLD) and subsequent progression to fibrosis is increasingly prevalent in people with HIV (PWH). We used noninvasive methods to stratify risk and identify associated factors of advanced fibrosis in PWH with NAFLD. Methods We conducted a retrospective study of PWH in our clinic from 2005 to 2022. We used liver imaging or biopsy reports to identify cases of hepatic steatosis after excluding specified etiologies. We used the Fibrosis-4 (FIB-4), NAFLD Fibrosis (NFS), and body mass index, aspartate transaminase/alanine transaminase ratio, and diabetes score scores to stratify fibrosis. We used logistic regression to identify factors associated with advanced fibrosis. Results Among 3959 PWH in care, 1201 had available imaging or liver biopsies. After exclusions, 114 of 783 PWH had evidence of hepatic steatosis (14.6%). Most were male (71.1%), with a median age of 47 years, and median body mass index of 30.1 kg/m2. Approximately 24% had lean NAFLD (ie, body mass index < 25 kg/m2). Based on the FIB-4 and NFS, 34 (29.8%) and 36 (31.6%) had advanced fibrosis, whereas 1 in 4 had low risk of fibrosis based on FIB-4, NFS, and BARD scores. In adjusted analysis using FIB-4, advanced fibrosis was associated with age > 45 years (adjusted odds ratio, 6.29; 95% confidence interval, 1.93–20.50) and hypoalbuminemia (adjusted odds ratio, 9.45; 95% confidence interval, 2.45–32.52) in addition to elevated transaminases and thrombocytopenia, whereas using the NFS did not identify associations with advanced fibrosis. Conclusions We found 14.6% of PWH had NAFLD, with 1 in 3 having advanced fibrosis. Our study provides practical insights into fibrosis risk stratification in HIV primary care settings. [ABSTRACT FROM AUTHOR]

Published
2024
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