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1. National Landscape of Human Immunodeficiency Virus-Positive Deceased Organ Donors in the United States.

Author

Werbel, William A, Brown, Diane M, Kusemiju, Oyinkansola T, Doby, Brianna L, Seaman, Shanti M, Redd, Andrew D, Eby, Yolanda, Fernandez, Reinaldo E, Desai, Niraj M, Miller, Jernelle, Bismut, Gilad A, Kirby, Charles S, Schmidt, Haley A, Clarke, William A, Seisa, Michael, Petropoulos, Christos J, Quinn, Thomas C, Florman, Sander S, Huprikar, Shirish, Rana, Meenakshi M, Friedman-Moraco, Rachel J, Mehta, Aneesh K, Stock, Peter G, Price, Jennifer C, Stosor, Valentina, Mehta, Shikha G, Gilbert, Alexander J, Elias, Nahel, Morris, Michele I, Mehta, Sapna A, Small, Catherine B, Haidar, Ghady, Malinis, Maricar, Husson, Jennifer S, Pereira, Marcus R, Gupta, Gaurav, Hand, Jonathan, Kirchner, Varvara A, Agarwal, Avinash, Aslam, Saima, Blumberg, Emily A, Wolfe, Cameron R, Myer, Kevin, Wood, R Patrick, Neidlinger, Nikole, Strell, Sara, Shuck, Marion, Wilkins, Harry, Wadsworth, Matthew, Motter, Jennifer D, Odim, Jonah, Segev, Dorry L, Durand, Christine M, Tobian, Aaron AR, Piquant, Dominque, Link, Katherine, Hemmersbach-Miller, Marion, Pearson, Thomas, Turgeon, Nicole, Lyon, G Marshall, Kitchens, William, Huckaby, Jeryl, Lasseter, A Francie, Elbein, Rivka, Roberson, April, Ferry, Elizabeth, Klock, Ethan, Cochran, Willa V, Morrison, Michelle, Rasmussen, Sarah, Bollinger, Juli, Sugarman, Jeremy, Smith, Angela R, Thomas, Margaret, Coakley, Margaret, Timpone, Joseph, Stucke, Alyssa, Haydel, Brandy, Dieter, Rebecca, Klein, Elizabeth J, Neumann, Henry, Gallon, Lorenzo, Goudy, Leah, Callegari, Michelle, Marrazzo, Ilise, Jackson, Towanda, Pruett, Timothy, Farnsworth, Mary, Locke, Jayme E, Mompoint-Williams, Darnell, Basinger, Katherine, Mekeel, Kristin, Nguyen, Phirum, Kwan, Joanne, Srisengfa, Tab, Chin-Hong, Peter, Rogers, Rodney, Simkins, Jacques, Munoz, Carlos, and Dunn, Ty

Subjects
Pediatric Research Initiative, HIV/AIDS, Infectious Diseases, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Infection, Good Health and Well Being, Anti-Retroviral Agents, HIV, HIV Infections, HIV Seropositivity, Humans, Integrases, Prospective Studies, Tissue Donors, United States, Viral Load, transplant, organ donation, drug resistance, HOPE in Action Investigators, Biological Sciences, Medical and Health Sciences, Microbiology
Abstract

BackgroundOrgan transplantation from donors with human immunodeficiency virus (HIV) to recipients with HIV (HIV D+/R+) presents risks of donor-derived infections. Understanding clinical, immunologic, and virologic characteristics of HIV-positive donors is critical for safety.MethodsWe performed a prospective study of donors with HIV-positive and HIV false-positive (FP) test results within the HIV Organ Policy Equity (HOPE) Act in Action studies of HIV D+/R+ transplantation (ClinicalTrials.gov NCT02602262, NCT03500315, and NCT03734393). We compared clinical characteristics in HIV-positive versus FP donors. We measured CD4 T cells, HIV viral load (VL), drug resistance mutations (DRMs), coreceptor tropism, and serum antiretroviral therapy (ART) detection, using mass spectrometry in HIV-positive donors.ResultsBetween March 2016 and March 2020, 92 donors (58 HIV positive, 34 FP), representing 98.9% of all US HOPE donors during this period, donated 177 organs (131 kidneys and 46 livers). Each year the number of donors increased. The prevalence of hepatitis B (16% vs 0%), syphilis (16% vs 0%), and cytomegalovirus (CMV; 91% vs 58%) was higher in HIV-positive versus FP donors; the prevalences of hepatitis C viremia were similar (2% vs 6%). Most HIV-positive donors (71%) had a known HIV diagnosis, of whom 90% were prescribed ART and 68% had a VL

Published
2022

2. Wait Time Advantage for Transplant Candidates With HIV Who Accept Kidneys From Donors With HIV Under the HOPE Act

Author

Motter, Jennifer D., Hussain, Sarah, Brown, Diane M., Florman, Sander, Rana, Meenakshi M., Friedman-Moraco, Rachel, Gilbert, Alexander J., Stock, Peter, Mehta, Shikha, Mehta, Sapna A., Stosor, Valentina, Elias, Nahel, Pereira, Marcus R., Haidar, Ghady, Malinis, Maricar, Morris, Michele I., Hand, Jonathan, Aslam, Saima, Schaenman, Joanna M., Baddley, John, Small, Catherine B., Wojciechowski, David, Santos, Carlos A.Q., Blumberg, Emily A., Odim, Jonah, Apewokin, Senu K., Giorgakis, Emmanouil, Bowring, Mary Grace, Werbel, William A., Desai, Niraj M., Tobian, Aaron A.R., Segev, Dorry L., Massie, Allan B., Durand, Christine M., Kusemiju, Oyinkansola, Barnaba, Brittany, Prizzi, Michelle, Liang, Tao, Barnes, Grace Link, Chahoud, Margaret, Wiles, James, Cochran, Willa, Morrison, Michelle, Storm, Kaitlyn, Apte, Anuj, Paredes, Linda, Kuffar, Bahati, Stearns, Quinten, Brown, Nadine, Chang, Amy, Haydel, Brandy M., Pearson, Thomas, Mehta, Aneesh K., Lyon, G. Marshall, Kitchens, William, Huckaby, Jeryl, Elbein, Rivka, Roberson, April, Ferry, Elizabeth, Coakley, Margaret, Akhran, Aleya, Timpone, Joseph, Stucke, Alyssa, Mompoint-Williams, Darnell, Locke, Jayme E., Weldon, Elaina P., Dieter, Rebecca, Klein, Elizabeth, Goudy, Leah, Callegari, Michelle, Gallon, Lorenzo, Hughes, Kailey, Pakstis, Diana Lynn, Silveira, Fernanda, Tomlin, Ricarda, Smith, Angela, Shah, Mita, Mekeel, Kristin, Nguyen, Phirum, Mills, Jeff, Bunnapradist, Suphamai, Gritsch, H. Albin, Moe, Ardis A., Silva, Rosemary, Marrazzo, Ilise D., Muthukumar, Thangamani, Chang, Amy, Hoz, Ricardo La, Hubbard, Jarrett, Mall, Mark, Santos, Carlos, Dunn, Ty, Sawinski, Deirdre, Najdzinowicz, Maryann, Chen, Jeanne M., Nagy, Jamie, and Brigle, Nathaniel

Published
2024
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4. Continued Slow Decay of the Residual Plasma Viremia Level in HIV-1–Infected Adults Receiving Long-term Antiretroviral Therapy

Author

Riddler, Sharon A, Aga, Evgenia, Bosch, Ronald J, Bastow, Barbara, Bedison, Margaret, Vagratian, David, Vaida, Florin, Eron, Joseph J, Gandhi, Rajesh T, Mellors, John W, Team, for the ACTG A5276s Protocol, Mirand, Amy, Klebert, Michael, Fry, Carrie, Dragavon, Joan, Koletar, Susan, Hite, Mark, Meixner, Linda, Seefried, Edward, Bagur, Jorge L Santana, Perez, Sigrid, Funk, Connie, Santos, Bartolo, Bailey, Vicki, Jackson, Brenda, Feinberg, Judith, Saemann, Michelle, Lindsey, Elizabeth, James, Tamara, Kronk, Catherine, Oakes, Jonathan, Adams, Mary, Hurley, Christine, Dunaway, Shelia, Storey, Sheryl S, Van Dam, Cornelius, Epperson, Kim, Tebas, Pablo, Thomas, Aleshia, Klevens, Lisa, Mattiucci, Sara, Walton, Trisha, Baum, Jane, Spitz, Teresa, DeMarco, Debra, Sha, Beverly E, Green, Tondria, Basler, Cathi, Griesmer, Christine, Aberg, Judith A, Cespedes, Michelle S, Valle, Sandra, Slamowitz, Debbie, Currier, Judith, Cajahuaringa, Vanessa, Taiwo, Babafemi, McGregor, Donna, Kumar, Princy, Timpone, Joseph, Albrecht, Mary, Kershaw, Andrea, Sax, Paul, Keenan, Cheryl, Daar, Eric, Lopez, Ruben, Luetkemeyer, Annie, Dwyer, Jay, Ellner, Jerrold, Linas, Benjamin, Hughes, Valery, Lopez-Detres, Luis, Davis, Traci, Whitely, Kim, Palmore, Melody, and Gunthel, Clifford

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Immunology, Infectious Diseases, HIV/AIDS, Sexually Transmitted Infections, Clinical Trials and Supportive Activities, Clinical Research, 5.2 Cellular and gene therapies, Infection, Adult, Anti-Retroviral Agents, Antiretroviral Therapy, Highly Active, CD4-CD8 Ratio, Female, HIV Infections, HIV-1, Humans, Longitudinal Studies, Male, Plasma, RNA, Viral, Viral Load, residual viremia, viral decay, single-copy assay, CD4/CD8 ratio, ACTG A5276s Protocol Team, Biological Sciences, Medical and Health Sciences, Microbiology, Biological sciences, Biomedical and clinical sciences, Health sciences
Abstract

UnlabelledWe measured plasma human immunodeficiency virus type 1 (HIV-1) RNA levels by means of single-copy assay in 334 participants receiving virologically suppressive antiretroviral therapy (ART). A residual viremia load of ≥1 copy/mL after 4 years of ART was predicted by a higher pre-ART HIV-1 RNA level, higher CD8(+) T-cell count during treatment, and a lower ratio of CD4+ T cells to CD8+ T cells during treatment but not by initial ART regimen. In a longitudinal subset of 64 individuals, continued decay of the plasma HIV-1 RNA level was observed, with an average annual decrease of 6% and an estimated half-life of 11.5 years. In contrast to prior reports, the persistent viremia level continues to slowly decline during years 4-12 of suppressive ART.Clinical trials registrationNCT00001137.

Published
2016

8. Comparison of the Metabolic Effects of Ritonavir-Boosted Darunavir or Atazanavir Versus Raltegravir, and the Impact of Ritonavir Plasma Exposure: ACTG 5257

Author

Ofotokun, Ighovwerha, Na, Lumine H, Landovitz, Raphael J, Ribaudo, Heather J, McComsey, Grace A, Godfrey, Catherine, Aweeka, Francesca, Cohn, Susan E, Sagar, Manish, Kuritzkes, Daniel R, Brown, Todd T, Patterson, Kristine B, Para, Michael F, Leavitt, Randi Y, Villasis-Keever, Angelina, Baugh, Bryan P, Lennox, Jeffrey L, Currier, Judith S, Team, for the AIDS Clinical Trials Group A5257, Saemann, Michelle, Baer, Jennifer, Koletar, Susan, Meixner, Linda, Seefried, Edward, Bailey, Vicki, Basham, Rebecca, Currin, David, Chicurel-Bayard, Miriam, Spitz, Teresa, Frain, Judy, Lindsey, Elizabeth, James, Tamara, Putnam, Beverly, Basler, Cathi, Dube, Michael P, Santos, Bartolo, Daar, Eric, Shaik, Sadia, Tebas, Pablo, Thomas, Aleshia, Bedimo, Roger, Mba, Michelle, Cohn, David, Moran, Fran, Bagur, Jorge L Santana, Dueño, Ileana Boneta, Taiwo, Babafemi, Berzins, Baiba, Chang, Emery, Palmer, Maria, Adams, Mary, Hurley, Christine, Lane, Timothy, Van Dam, Cornelius, Tashima, Karen, Patterson, Helen, del Rio, Carlos, Patrick, Ericka, Markowitz, Norman, Brar, Indira, Arduino, Roberto C, Martinez, Maria Laura, Kim, Rose, Smith, Yolanda, Bolivar, Hector, Fischl, Margaret A, Telzak, Edward, Cindrich, Richard, Sax, Paul, Keenan, Cheryl, Whitely, Kim, Davis, Traci, MacArthur, Rodger D, Farrough, Marti, Aberg, Judith A, Cespedes, Michelle S, Dunaway, Shelia, Storey, Sheryl, Gallant, Joel, Wiggins, Ilene, Sha, Beverly, Navarro, Veronica, Watson, Vicky, Nixon, Daniel, Luetkemeyer, Annie, Dwyer, Jay, Allen, Kristen, Walton, Patricia, Kumar, Princy, Timpone, Joseph, McKellar, Mehri, Granholm, Jacquelin, Yin, Michael T, Torres, Madeline, Valle, Sandra, Slamowitz, Debbie, Davis, Charles E, Blattner, William A, Linus, Benjamin, and Albrecht, Mary

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, 6.1 Pharmaceuticals, Adult, Anti-HIV Agents, Atazanavir Sulfate, Blood Glucose, Darunavir, Drug Therapy, Combination, Female, HIV Infections, HIV-1, Humans, Lipids, Male, Raltegravir Potassium, Ritonavir, HIV/AIDS, cART, lipids, metabolic syndrome, AIDS Clinical Trials Group (ACTG) A5257 Team, Biological Sciences, Medical and Health Sciences, Microbiology, Clinical sciences
Abstract

BackgroundMetabolic effects following combination antiretroviral therapy (cART) vary by regimen type. Changes in metabolic effects were assessed following cART in the AIDS Clinical Trials Group (ACTG) A5257 study, and correlated with plasma ritonavir trough concentrations (C24).MethodsTreatment-naive adult subjects were randomized to ritonavir-boosted atazanavir or darunavir, or raltegravir-based cART. Changes in lipids and other metabolic outcomes over time were estimated. Differences between arms were estimated with 97.5% confidence intervals and compared using pairwise Student t tests. Associations between ritonavir C24 and lipid changes at week 48 were evaluated via linear regression.ResultsAnalyses included 1797 subjects with baseline fasting data. Baseline lipid profiles and metabolic syndrome rates (approximately 21%) were similar across arms. Comparable increases occurred in total cholesterol, triglycerides, and low-density lipoprotein cholesterol with the boosted protease inhibitors (PIs); each PI had greater increases relative to raltegravir (all P ≤ .001 at week 96). Metabolic syndrome incident rates by week 96 (approximately 22%) were not different across arms. Ritonavir C24 was not different by arm (P = .89) (median, 69 ng/mL and 74 ng/mL in the atazanavir and darunavir arms, respectively) and were not associated with changes in lipid measures (all P > .1).ConclusionsRaltegravir produced the most favorable lipid profile. Metabolic syndrome rates were high at baseline and increased to the same degree in all arms. Ritonavir C24 was not different in the PI arms and had no relationship with the modest but comparable increases in lipids observed with either atazanavir or darunavir. The long-term clinical significance of the lipid changes noted with the PIs relative to raltegravir deserves further evaluation.Clinical trials registrationNCT 00811954.

Published
2015

9. Attributable mortality from extensively drug-resistant gram-negative infections using propensity-matched tracer antibiotic algorithms

Author

Kadri, Sameer S., Strich, Jeffrey R., Swihart, Bruce J., Hohmann, Samuel, Dekker, John P., Palmore, Tara, Bonne, Stephanie, Freeman, Bradley, Raybould, Jillian, Shah, Nirav G., Patel, Devang, Husson, Jennifer, Jacobs, Mitchell D., Duong, Lan, Follmann, Dean, Hooper, David C., Timpone, Joseph, and Danner, Robert L.

Published
2019
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12. 652. Ceftazidime-avibactam Alone or as Combination Therapy? Multicenter Retrospective Cohort Analysis of Clinical Outcomes in Patients with Carbapenem-resistant Gram-negative Infection

Author

Mishuk, Ahmed Ullah, primary, Strich, Jeffrey R, additional, Warner, Sarah, additional, Sun, Junfeng, additional, Malik, Seidu, additional, Lawandi, Alexander, additional, Kondo, Maiko, additional, Satlin, Michael J, additional, Chandorkar, Aditya, additional, Heil, Emily L, additional, Morales, Megan K, additional, Mathur, Anisha, additional, Timpone, Joseph, additional, Wooten, Darcy, additional, Sweeney, Daniel, additional, Pan, Jonathan, additional, Raybould, Jillian, additional, Bonne, Stephanie, additional, Colindres, Roberto, additional, Boucher, Helen W, additional, Buckman, Sara, additional, Furukawa, Daisuke, additional, Uslan, Daniel, additional, Hohmann, Samuel F, additional, and Kadri, Sameer S, additional

Published
2022
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18. The Safety and Pharmacokinetics of Single-Agent and Combination Therapy with Megestrol Acetate and Dronabinol for the Treatment of HIV Wasting Syndrome

Author

Timpone, Joseph G., Wright, David J., Li, Ning, Egorin, Merrill J., Enama, Mary E., Mayers, Jacqueline, Galetto, Giorgio, Gagnon, Suzanne, Vargo, Jeri, Chirgwin, Keith, Marcel, Adrien, Cohn, David, Hopkins, Beverly, Dudley, Michael, Geletko, Sandra, Standiford, Harold, Cervino, Karen, Greenspan, Debra, Mushatt, David M., Powderly, William, Meyers, Mark, Sampson, James H., McMillan, Gregory, Novak, Richard, Moreira, Luiz, Nahas, Gabriel G., editor, Sutin, Kenneth M., editor, Harvey, David, editor, Agurell, Stig, editor, Pace, Nicholas, editor, and Cancro, Robert, editor

Published
1999
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28. Sex differences in atazanavir pharmacokinetics and associations with time to clinical events: AIDS Clinical Trials Group Study A5202

Author

Venuto, Charles S., Mollan, Katie, Ma, Qing, Daar, Eric S., Sax, Paul E., Fischl, Margaret, Collier, Ann C., Smith, Kimberly Y., Tierney, Camlin, Morse, Gene D., Bolivar, Hector H., Navarro, Sandra, Koletar, Susan L., Gochnour, Diane, Seefried, Edward, Hoffman, Julie, Feinberg, Judith, Saemann, Michelle, Patterson, Kristine, Pittard, Donna, Currin, David, Upton, Kerry, Saag, Michael, Ray, Graham, Johnson, Steven, Santos, Bartolo, Funk, Connie A., Morgan, Michael, Jackson, Brenda, Tebas, Pablo, Thomas, Aleshia, Kim, Ge-Youl, Klebert, Michael K., Santana, Jorge L., Marrero, Santiago, Norris, Jane, Valle, Sandra, Cox, Gary Matthew, Silberman, Martha, Shaik, Sadia, Lopez, Ruben, Vasquez, Margie, Daskalakis, Demetre, Megill, Christina, Stroberg, Todd, Shore, Jessica, Taiwo, Babafemi, Goldman, Mitchell, Boston, Molly, Lennox, Jeffrey, del Rio, Carlos, Lane, Timothy W., Epperson, Kim, Luetkemeyer, Annie, Payne, Mary, Gripshover, Barbara, Antosh, Dawn, Reid, Jane, Adams, Mary, Storey, Sheryl S., Dunaway, Shelia B., Gallant, Joel, Wiggins, Ilene, Smith, Kimberly Y., Swiatek, Joan A., Timpone, Joseph, Kumar, Princy, Moe, Ardis, Palmer, Maria, Gothing, Jon, Delaney, Joanne, Whitely, Kim, Anderson, Ann Marie, Hammer, Scott M., Yin, Michael T., Jain, Mamta, Petersen, Tianna, Corales, Roberto, Hurley, Christine, Henry, Keith, Bordenave, Bette, Youmans, Amanda, Albrecht, Mary, Pollard, Richard B., Olusanya, Abimbola, Skolnik, Paul R., Adams, Betsy, Tashima, Karen T., Patterson, Helen, Ukwu, Michelle, Rogers, Lauren, Balfour, Henry H., Jr, Fox, Kathy A., Swindells, Susan, Van Meter, Frances, Robbins, Gregory, Burgett-Yandow, Nicole, Davis, Charles E., Jr, Boyce, Colleen, OʼBrien, William A., Casey, Gerianne, Morse, Gene D., Hsaio, Chiu-Bin, Meier, Jeffrey L., Stapleton, Jack T., Mildvan, Donna, Revuelta, Manuel, Currin, David, El Sadr, Wafaa, Loquere, Avelino, El-Daher, Nyef, Johnson, Tina, Gross, Robert, Maffei, Kathyrn, Hughes, Valery, Sturge, Glenn, McMahon, Deborah, Rutecki, Barbara, Wulfsohn, Michael, Cheng, Andrew, Bischofberger, Norbert, Dix, Lynn, and Liao, Qiming

Published
2014
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30. HIV type 1 chemokine coreceptor use among antiretroviral-experienced patients screened for a clinical trial of a CCR5 inhibitor: AIDS Clinical Trial Group A5211

Author

Wilkin, Timothy J., Su, Zhaohui, Kuritzkes, Daniel R., Hughes, Michael, Flexner, Charles, Gross, Robert, Coakley, Eoin, Greaves, Wayne, Godfrey, Catherine, Skolnik, Paul R., Timpone, Joseph, Rodriguez, Benigno, and Gulick, Roy M.

Subjects
Chemokine receptors -- Usage, HIV infection -- Development and progression, HIV infection -- Research, Health, Health care industry
Published
2007

31. Infections in Liver Transplantation

Author

Mohanraj, B. Sharmila, Rangnekar, Amol S., and Timpone, Joseph G.

Subjects
Healthcare-acquired infections, surgical procedures, operative, Deceased donor transplant, Antirejection drugs, Orthotopic liver transplant, Opportunistic infections, Recurrence of viral hepatitis post-transplant, End-stage liver disease, Infectious complications of liver transplant, Article, Acute liver failure, Chronic hepatitis C infection, Living donor transplant
Abstract

Liver transplantation has become an important treatment modality for patients with end-stage liver disease/cirrhosis, acute liver failure, and hepatocellular carcinoma. Although surgical techniques and immunosuppressive regimens for liver transplantation have improved significantly over the past 20 years, infectious complications continue to contribute to the morbidity and mortality in this patient population. The use of standardized screening protocols for both donors and recipients, coupled with targeted prophylaxis against specific pathogens, has helped to mitigate the risk of infection in liver transplant recipients. Patients with chronic liver disease and cirrhosis have immunological deficits that place them at increased risk for infection while awaiting liver transplantation. The patient undergoing liver transplantation is prone to develop healthcare-acquired infections due to multidrug-resistant organisms that could potentially affect patient outcomes after transplantation. The complex nature of liver transplant surgery that involves multiple vascular and hepatobiliary anastomoses further increases the risk of infection after liver transplantation. During the early post-transplantation period, healthcare-acquired bacterial and fungal infections are the most common types of infection encountered in liver transplant recipients. The period of maximal immunosuppression that occurs at 1–6 months after transplantation can be complicated by opportunistic infections due to both primary infection and reactivation of latent infection. Severe community-acquired infections can complicate the course of liver transplantation beyond 12 months after transplant surgery. This chapter provides an overview of liver transplantation including indications, donor-recipient selection criteria, surgical procedures, and immunosuppressive therapies. A focus on infections in patients with chronic liver disease/cirrhosis and an overview of the specific infectious complications in liver transplant recipients are presented.

Published
2018

34. Failure of cytarabine in progressive multifocal leukoencephalopathy associated with human immunodeficiency virus infection

Author

Hall, Colin D., Dafni, Urania, Simpson, David, Clifford, David, Wetherill, Patricia E., Cohen, Bruce, McArthur, Justin, Hollander, Harry, Yainnoutsos, Constantin, Major, Eugene, Millar, Linda, and Timpone, Joseph

Subjects
HIV infection -- Complications, Leukoencephalopathy, Progressive multifocal -- Drug therapy, Cytarabine -- Evaluation
Abstract

HIV patients with progressive multifocal leukoencephalopathy do not appear to benefit from the drug cytabarine or the typical drugs used to treat AIDS. Progressive multifocal leukoencephalopathy is a viral infection of the brain that is enhanced by prolonged immunosuppression. Researchers randomly assigned 57 HIV patients with this infection to take the AIDS drug zidovudine plus didanosine or stavudine or cytarabine administered in two different ways. Only 7 patients completed the 24-week treatment, and survival rates were similar in all three groups.

Published
1998

35. Treatment of human immunodeficiency virus infection with saquinavir, zidovudine, and zalcitabine

Author

Collier, Ann C., Coombs, Robert W., Schoenfeld, David A., Bassett, Roland L., Timpone. Joseph, Baruch, Alice, Jones, Michelle, Facey, Karen, Whitacre, Caroline, McAuliffe, Vincent J., Friedman, Harvey M., Merigan, Thomas C., Reichman, Richard C., Hooper, Carol, and Corey, Lawrence

Subjects
HIV infection -- Drug therapy, Protease inhibitors -- Evaluation, Nucleoside analogs -- Evaluation, Drug therapy, Combination -- Evaluation
Abstract

Combined treatment with sasquinavir, zidovudine and zalcitabine appears to be more effective at reducing HIV-1 replication, increasing CD4+ cells counts and decreasing levels of other activation markers in HIV-infected patients than does treatment combining zidovudine with only one of the two other drugs. Sasquinavir is a protease inhibitor, while zidovudine and zalcitabine are nucleosides. A total of 302 people infected with HIV were given either saquinavir in combination with zidovudine and zalcitabine, or zidovudine with either saquinavir or zalcitabine. CD4+ rose temporarily in all three groups, but counts remained higher for a longer period of time in people receiving all three drugs. Those receiving all three drugs also showed greater reductions in plasma HIV and greater decreases in serum neopterin and beta2-microglobulin levels, both of which increase as HIV infection spreads.

Published
1996

37. Bartonella Endocarditis and Pauci-Immune Glomerulonephritis

Author

Raybould, Jillian E., Raybould, Alison L., Morales, Megan K., Zaheer, Misbah, Lipkowitz, Michael S., Timpone, Joseph G., and Kumar, Princy N.

Subjects
hemic and lymphatic diseases, pauci-immune glomerulonephritis, bacteria, endocarditis-associated glomerulonephritis, cardiovascular diseases, bacterial infections and mycoses, Review Articles, Bartonella endocarditis, culture-negative endocarditis
Abstract

Among culture-negative endocarditis in the United States, Bartonella species are the most common cause, with Bartonella henselae and Bartonella quintana comprising the majority of cases. Kidney manifestations, particularly glomerulonephritis, are common sequelae of infectious endocarditis, with nearly half of all Bartonella patients demonstrating renal involvement. Although a pauci-immune pattern is a frequent finding in infectious endocarditis–associated glomerulonephritis, it is rarely reported in Bartonella endocarditis. Anti–neutrophil cytoplasmic antibody (ANCA) positivity can be seen with many pathogens causing endocarditis and has been previously reported with Bartonella species. In addition, ANCA-associated vasculitis can also present with renal and cardiac involvement, including noninfectious valvular vegetations and pauci-immune glomerulonephritis. Given the overlap in their clinical presentation, it is difficult to differentiate between Bartonella endocarditis and ANCA-associated vasculitis but imperative to do so to guide management decisions. We present a case of ANCA-positive Bartonella endocarditis with associated pauci-immune glomerulonephritis that was successfully treated with medical management alone.

Published
2016

41. Race/Ethnicity and Protease Inhibitor Use Influence Plasma Tenofovir Exposure in Adults Living with HIV-1 in AIDS Clinical Trials Group Study A5202

Author

Bednasz, Cindy J., primary, Venuto, Charles S., additional, Ma, Qing, additional, Daar, Eric S., additional, Sax, Paul E., additional, Fischl, Margaret A., additional, Collier, Ann C., additional, Smith, Kimberly Y., additional, Tierney, Camlin, additional, Acosta, Edward P., additional, Mager, Donald E., additional, Morse, Gene D., additional, Bolivar, Hector H., additional, Navarro, Sandra, additional, Koletar, Susan L., additional, Gochnour, Diane, additional, Seefried, Edward, additional, Hoffman, Julie, additional, Feinberg, Judith, additional, Saemann, Michelle, additional, Patterson, Kristine, additional, Pittard, Donna, additional, Currin, David, additional, Upton, Kerry, additional, Saag, Michael, additional, Ray, Graham, additional, Johnson, Steven, additional, Santos, Bartolo, additional, Funk, Connie A., additional, Morgan, Michael, additional, Jackson, Brenda, additional, Tebas, Pablo, additional, Thomas, Aleshia, additional, Kim, Ge-Youl, additional, Klebert, Michael K., additional, Santana, Jorge L., additional, Marrero, Santiago, additional, Norris, Jane, additional, Valle, Sandra, additional, Cox, Gary Matthew, additional, Silberman, Martha, additional, Shaik, Sadia, additional, Lopez, Ruben, additional, Vasquez, Margie, additional, Daskalakis, Demetre, additional, Megill, Christina, additional, Stroberg, Todd, additional, Shore, Jessica, additional, Taiwo, Babafemi, additional, Goldman, Mitchell, additional, Boston, Molly, additional, Lennox, Jeffrey, additional, del Rio, Carlos, additional, Lane, Timothy W., additional, Epperson, Kim, additional, Luetkemeyer, Annie, additional, Payne, Mary, additional, Gripshover, Barbara, additional, Antosh, Dawn, additional, Reid, Jane, additional, Adams, Mary, additional, Storey, Sheryl S., additional, Dunaway, Shelia B., additional, Gallant, Joel, additional, Wiggins, Ilene, additional, Swiatek, Joan A., additional, Timpone, Joseph, additional, Kumar, Princy, additional, Moe, Ardis, additional, Palmer, Maria, additional, Gothing, Jon, additional, Delaney, Joanne, additional, Whitely, Kim, additional, Anderson, Ann Marie, additional, Hammer, Scott M., additional, Yin, Michael T., additional, Jain, Mamta, additional, Petersen, Tianna, additional, Corales, Roberto, additional, Hurley, Christine, additional, Henry, Keith, additional, Bordenave, Bette, additional, Youmans, Amanda, additional, Albrecht, Mary, additional, Pollard, Richard B., additional, Olusanya, Abimbola, additional, Skolnik, Paul R., additional, Adams, Betsy, additional, Tashima, Karen T., additional, Patterson, Helen, additional, Ukwu, Michelle, additional, Rogers, Lauren, additional, Balfour, Henry H., additional, Fox, Kathy A., additional, Swindells, Susan, additional, Van Meter, Frances, additional, Robbins, Gregory, additional, Burgett-Yandow, Nicole, additional, Davis, Charles E., additional, Boyce, Colleen, additional, O’Brien, William A., additional, Casey, Gerianne, additional, Hsaio, Chiu-Bin, additional, Meier, Jeffrey L., additional, Stapleton, Jack T., additional, Mildvan, Donna, additional, Revuelta, Manuel, additional, El Sadr, Wafaa, additional, Loquere, Avelino, additional, El-Daher, Nyef, additional, Johnson, Tina, additional, Gross, Robert, additional, Maffei, Kathyrn, additional, Hughes, Valery, additional, Sturge, Glenn, additional, McMahon, Deborah, additional, Rutecki, Barbara, additional, Wulfsohn, Michael, additional, Cheng, Andrew, additional, Bischofberger, Norbert, additional, Dix, Lynn, additional, and Liao, Qiming, additional

Published
2019
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42. HOPE in action: A prospective multicenter pilot study of liver transplantation from donors with HIV to recipients with HIV

Author

Durand, Christine M., Florman, Sander, Motter, Jennifer D., Brown, Diane, Ostrander, Darin, Yu, Sile, Liang, Tao, Werbel, William A., Cameron, Andrew, Ottmann, Shane, Hamilton, James P., Redd, Andrew D., Bowring, Mary G., Eby, Yolanda, Fernandez, Reinaldo E., Doby, Brianna, Labo, Nazzarena, Whitby, Denise, Miley, Wendell, Friedman‐Moraco, Rachel, Turgeon, Nicole, Price, Jennifer C., Chin‐Hong, Peter, Stock, Peter, Stosor, Valentina, Kirchner, Varvara A., Pruett, Timothy, Wojciechowski, David, Elias, Nahel, Wolfe, Cameron, Quinn, Thomas C., Odim, Jonah, Morsheimer, Megan, Mehta, Sapna A., Rana, Meenakshi M., Huprikar, Shirish, Massie, Allan, Tobian, Aaron A. R., Segev, Dorry L., Pereira, Marcus, Piquant, Dominique, Edwards, Carolyn, Ranganna, Karthik M, Link, Katherine, Pearson, Thomas, Mehta, Aneesh K, Lyon, G. Marshall, Kitchens, William, Huckaby, Jeryl, Elbein, Rivka, Roberson, April, Ferry, Elizabeth, Adebiyi, Margaret, Adebiyi, Oluwafisayo, Kubal, Chandrahekhar, Ambinder, Richard, Barnaba, Brittany, Bismut, Gilad, Bollinger, Juli, Boyarsky, Brian, Charles, Curtisha, Cochran, Willa V, Desai, Niraj N, Doby, Brianna, Johnstone, Jaylyn, Kirby, Charles, Klock, Ethan, Kusemiju, Oyinkansola, Miller, Jernelle, Morrison, Michelle, Prizzi, Michelle, Schmidt, Haley, Rasmussen, Sarah, Sugarman, Jeremy, Seaman, Shanti, Thomas, Margret, Akhran, Aleya, Coakley, Margaret, Cooper, Matthew, Gilbert, Alexander, Stucke, Alyssa, Timpone, Joseph, Castillo‐Lugo, Jose A, Townsend, Melba, Haydel, Brandy M., Goudy, Leah, Gallon, Lorenzo, Dieter, Rebecca, Deterville, Cecilia, Klein, Elizabeth, Neumann, Henry, Weldon, Elaina P, Hand, Jonathan, Smith, Angela R, Blumberg, Emily A, Donaghy, Eileen, Dunn, Ty, Sawinski, Deirdre, Mall, Mark, Santos, Carlos A. Q, Basinger, Katherine, Locke, Jayme E, Mehta, Shikha, Mompoint‐Williams, Darnell, Gadzhyan, Janette, Schaenman, Joanna, Aslam, Saima, Mekeel, Kristin, Nguyen, Phirum, Chao, Ada, Kwan, Joanne, Rogers, Rodney, Srisengf, Tab, Apewokin, Senu, Harrison, Kathleen, Kramer, Samantha, Wilkinson, Rachel, Benamu, Esther, Spaggiari, Mario, Bruno, Kelly, Brogden, Gregory, Husson, Jennifer, Jeffery, Alicia, Marrazzo, Ilise D, Morris, Michele I, Munoz, Carlos, Simkins, Jacques, Farnsworth, Mary, Haidar, Ghady, Hughes Kramer, Kailey, Pakstis, Diana Lynn, Silveira, Fernanda, Baah, Whitney, Carlson, Emily, La Hoz, Ricardo M, Agarwal, Avinash, Doyle, Alden, Nagy, Jamie, Baldecchi, Mary, Brigle, Nathaniel, Gupta, Gaurav, Butkus‐Small, Catherine, Muthukumar, Thangamani, Malinis, Maricar, and Tomlin, Ricarda

Abstract

Liver transplantation (LT) from donors‐with‐HIV to recipients‐with‐HIV (HIV D+/R+) is permitted under the HOPE Act. There are only three international single‐case reports of HIV D+/R+ LT, each with limited follow‐up. We performed a prospective multicenter pilot study comparing HIV D+/R+ to donors‐without‐HIV to recipients‐with‐HIV (HIV D−/R+) LT. We quantified patient survival, graft survival, rejection, serious adverse events (SAEs), human immunodeficiency virus (HIV) breakthrough, infections, and malignancies, using Cox and negative binomial regression with inverse probability of treatment weighting. Between March 2016–July 2019, there were 45 LTs (8 simultaneous liver‐kidney) at 9 centers: 24 HIV D+/R+, 21 HIV D−/R+ (10 D− were false‐positive). The median follow‐up time was 23 months. Median recipient CD4 was 287 cells/µL with 100% on antiretroviral therapy; 56% were hepatitis C virus (HCV)‐seropositive, 13% HCV‐viremic. Weighted 1‐year survival was 83.3% versus 100.0% in D+ versus D− groups (p= .04). There were no differences in one‐year graft survival (96.0% vs. 100.0%), rejection (10.8% vs. 18.2%), HIV breakthrough (8% vs. 10%), or SAEs (all p> .05). HIV D+/R+ had more opportunistic infections, infectious hospitalizations, and cancer. In this multicenter pilot study of HIV D+/R+ LT, patient and graft survival were better than historical cohorts, however, a potential increase in infections and cancer merits further investigation. A multicenter study of HIV+ donor to HIV+ recipient liver transplantation under the HOPE Act shows that patient and graft survival were better than historical cohorts, but the possible increased incidence of infections and cancer merits further investigation.

Published
2022
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43. Phase I study of atevirdine mesylate (U-87201E) monotherapy in HIV-1-infected patients

Author

Demeter, Lisa M., Meehan, Patricia M., Morse, Gene, Fischl, Margaret A., Para, Michael, Powderly, William, Leedom, John, Holden-Wiltse, Jeanne, Greisberger, Carol, Wood, Kenneth, Timpone, Joseph, Jr., Wathen, Lynne K., Nevin, Thomas, Resnick, Lionel, Batts, Donald H., and Reichman, Richard C.

Subjects
HIV infection -- Drug therapy, Reverse transcriptase inhibitors -- Evaluation, Health
Abstract

Further research is needed to determine whether atevirdine mesylate (U-87201E) is effective in treating HIV infection. This drug belongs to a class of AIDS drugs called non-nucleoside reverse transcriptase inhibitors. In a study of 34 HIV-infected patients, the drug did not substantially lower viral levels or increase T cell counts. However, in 41% of the patients, the virus became resistant to the drug. This resistance might not develop if the drug is given in combination with other AIDS drugs such as zidovudine.

Published
1998

45. A phase-I study of the safety, pharmacokinetics, and antiviral activity of combination didanosine and ribavirin in patients with HIV-1 disease

Author

Japour, Anthony J., Lertora, Juan J., Meehan, Patricia M., Erice, Alejo, Connor, James D., Griffith, Brigitte P., Clax, Pamela A., Holden-Wiltse, Jeanne, Hussey, S., Walesky, Mary, Cooney, Elizabeth, Pollard, Richard, Timpone, Joseph, McLaren, Colin, Johanneson, Nils, Wood, Kenneth, Booth, David K., Bassiakos, Yannis, and Crumpacker, Clyde S.

Subjects
HIV infection -- Drug therapy, Didanosine -- Evaluation, Ribavirin -- Evaluation, Health
Abstract

The combination of ribavirin and ddI appears to be effective in treating HIV infection. Ribavirin enhances the activation of ddI in the body, thus augmenting its effectiveness. Researchers evaluated the drug combination in 19 patients, who received ddI alone for 4 weeks and then in combination with ribavirin for the remainder of the 12-week study. Only 22% experienced a reaction to the drugs. The drug combination reduced the levels of virus in the blood and also raised CD4 T cell counts. However, in 53% of the patients, the virus developed a gene mutation that would allow it to resist the drugs.

Published
1996

46. Nevirapine, zidovudine, and didanosine compared with zidovudine and didanosine in patients with HIV-1 infection: a randomized, double-blind, placebo-controlled trial

Author

D'Aquila, Richard T., Hughes, Michael D., Johnson, Victoria A., Fischl, Margaret A., Sommadossi, Jean-Pierre, Liou, Song-heng, Timpone, Joseph, Myers, Maureen, Basgoz, Nesli, Niu, Manette, and Hirsch, Martin S.

Subjects
HIV infection -- Drug therapy, Drug therapy, Combination -- Evaluation, Antiviral agents -- Evaluation, Didanosine -- Evaluation, Zidovudine -- Evaluation, Health
Abstract

Objective: To study the addition of a third human immunodeficiency virus type 1 (HIV-1) reverse transcriptase inhibitor, nevirapine, to the combination of zidovudine and didanosine. Design: A 48-week, randomized, double-blind, placebo-controlled trial at 16 AIDS (acquired immunodeficiency syndrome) Clinical Trials Units. Patients: 398 adults who had HIV-1 infection, had 350 or fewer [CD4.sup.+] T lymphocytes/[mm.sup.3], and had had more than 6 months of previous nucleoside therapy. Intervention: 1) Either nevirapine or placebo (200 mg/d for 2 weeks, then 400 mg/d thereafter) and 2) open-label zidovudine (600 mg/d) and didanosine (400 mg/d for patients weighing--60 kg). Measurements: [CD4.sup.+] T lymphocyte counts, time to first HIV-1 disease progression event or death, adverse events, and nevirapine levels in plasma samples taken at random were measured in all patients. Plasma levels of HIV-1 RNA; HIV-1 infectivity titer in peripheral blood mononuclear cells; serum p24 antigen levels; and plasma levels of zidovudine and didanosine were measured in patients enrolled at half the study sites. Results: After 48 weeks of study treatment, the patients assigned to the triple-combination regimen (nevirapine, zidovudine, and didanosine) had an 18% higher mean absolute CD4 cell count (95% CI, 7% to 29%; P = 0.001), a 0.32 [log.sub.10] lower mean infectious HIV-1 titer in peripheral blood mononuclear cells (CI, 0.05 to 0.59 [log.sub.10] infectious units per million cells; P = 0.023), and a 0.25 [log.sub.10] lower mean plasma HIV-1 RNA level (CI, 0.03 to 0.48 [log.sub.10] RNA copies/mL; P = 0.028) than did patients assigned to the double-combination regimen (zidovudine and didanosine). Severe rashes were more common among patients assigned to receive the triple combination (9% compared with 2%; P = 0.002). Risk for disease progression did not differ between the two groups (relative hazard of the triple-combination group, 1.24 [CI, 0.75 to 2.06]; P > 0.2), although the study had only moderate power to detect a major difference. Conclusions: Adding nevirapine to zidovudine and didanosine improved the long-term immunologic and virologic effects of therapy and was associated with severe rash among the patients studied, who had had extensive previous therapy. These results support 1) the continuing development of combinations of more than two antiretroviral drugs to increase and prolong HIV-1 suppression and 2) the potential utility of nevirapine in combination regimens., Combining nevirapine, zidovudine, and didanosine appears to maintain CD4 counts and reduce viral load more effectively than zidovudine and didanosine alone. However, patients taking the triple combination were more likely to develop severe rash. Researchers randomly assigned 398 HIV-infected patients with prior prolonged nucleoside therapy and CD4 cell counts of 350 or less to 48 weeks of treatment with either all three drugs or to zidovudine and didanosine plus placebo. CD4 counts declined an average of 15% with the triple combination versus 33% with the double combination. Viral titers in white blood cells declined by 54% and HIV-1 RNA plasma content declined by 20% with the triple combination versus a viral titer decline of 5% and an RNA plasma content rise of 44% with the double combination. However, similar percentages of both groups, 17% and 14% respectively, experienced disease progression or death, and 9% of those taking the triple combination experienced severe rash versus 2% taking the double combination.

Published
1996

48. Verruconis Gallopava

Author

Grewal, Harkiran K., primary, Kumar, Princy N., additional, Shah, Namrata, additional, and Timpone, Joseph G., additional

Published
2018
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