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153. HIV Salvage Therapy Does Not Require Nucleoside Reverse Transcriptase Inhibitors: A Randomized, Controlled Trial

Author

Hodder, Sally, Fichtenbaum, Carl J., Tashima, Karen T., Eron, Joseph J., Haubrich, Richard H., Klingman, Karin L., Ritz, Justin, Santana, Jorge L., Gandhi, Rajesh T., Wilkin, Timothy, Johnson, Victoria A., Smeaton, Laura M., and Andrade, Adriana

Subjects
immune system diseases, virus diseases
Abstract

Nucleoside reverse transcriptase inhibitors (NRTIs) are often included in antiretroviral (ARV) regimens in treatment-experienced patients in the absence of data from randomized trials.

Published
2015
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154. A Phase III Comparative Study of the Efficacy and Tolerability of Three Non-Nucleoside Reverse Transcriptase Inhibitor-Sparing Antiretroviral Regimens for Treatment-Naïve HIV-1-Infected Volunteers: A Randomized, Controlled Trial

Author

Lennox, Jeffrey L., Landovitz, Raphael J., Ribaudo, Heather J., Ofotokun, Ighovwerha, Na, Lumine H., Godfrey, Catherine, Kuritzkes, Daniel R., Sagar, Manish, Brown, Todd T., Cohn, Susan E., McComsey, Grace A., Aweeka, Francesca, Fichtenbaum, Carl J., Presti, Rachel M., Koletar, Susan L., Haas, David W., Patterson, Kristine B., Benson, Constance A., Baugh, Bryan P., Leavitt, Randi Y., Rooney, James F., Seekins, Daniel, and Currier, Judith S.

Subjects
Article
Published
2014

155. PRE-EXPOSURE PROPHYLAXIS PRODUCT CHOICE IN US PARTICIPANTS IN HPTN 083.

Author

Clement, Meredith E., Zhe Wang, Fichtenbaum, Carl J., Thomas, Schuyler, Bazan, Jose A., Richardson, Paul, Spinelli, Matthew A., Hanscom, Brett, Rinehart, Alex R., Rooney, Jim, Adeyeye, Adeola, McCauley, Marybeth, Cohen, Myron S., Grinsztejn, Beatriz, and Landovitz, Raphael J.

Published
2023

156. CHANGES IN BODY MASS INDEX WITH INTEGRASE INHIBITOR USE IN REPRIEVE.

Author

Kileel, Emma, Malvestutto, Carlos, Lo, Janet, Fitch, Kathleen V., Fichtenbaum, Carl J., Aberg, Judith A., Zanni, Markella V., Martinez, Esteban, Okeke, Nwora Lance, Kumar, Princy, Joao, Esau, McCallum, Sara, Douglas, Pam S., Ribaudo, Heather J., and Grinspoon, Steven K.

Published
2023

158. Regimen selection in the OPTIONS trial of HIV salvage therapy: drug resistance, prior therapy, and race–ethnicity determine the degree of regimen complexity

Author

Tashima, Karen T., primary, Mollan, Katie R., additional, Na, Lumine, additional, Gandhi, Rajesh T., additional, Klingman, Karin L., additional, Fichtenbaum, Carl J., additional, Andrade, Adriana, additional, Johnson, Victoria A., additional, Eron, Joseph J., additional, Smeaton, Laura, additional, and Haubrich, Richard H., additional

Published
2015
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159. Less Bone Loss With Maraviroc- Versus Tenofovir-Containing Antiretroviral Therapy in the AIDS Clinical Trials Group A5303 Study

Author

Taiwo, Babafemi O., primary, Chan, Ellen S., additional, Fichtenbaum, Carl J., additional, Ribaudo, Heather, additional, Tsibris, Athe, additional, Klingman, Karin L., additional, Eron, Joseph J., additional, Berzins, Baiba, additional, Robertson, Kevin, additional, Landay, Alan, additional, Ofotokun, Igho, additional, and Brown, Todd, additional

Published
2015
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160. Lipoprotein Changes in HIV-Infected Antiretroviral-Naïve Individuals after Starting Antiretroviral Therapy: ACTG Study A5152s Stein: Lipoprotein Changes on Antiretroviral Therapy

Author

Stein, James H., Komarow, Lauren, Cotter, Bruno R., Currier, Judith S., Dubé, Michael P., Fichtenbaum, Carl J., Gerschenson, Mariana, Mitchell, Carol K.C., Murphy, Robert L., Squires, Kathleen, Parker, Robert A., and Torriani, Francesca J.

Subjects
Article
Abstract

BACKGROUND: Dyslipidemia is a frequent complication of antiretroviral therapy (ART) for patients with human immunodeficiency virus infection (HIV). The effects of ART on lipoproteins are less well-understood, and have not been investigated in a prospective study where assignment to ART is randomized. OBJECTIVE: To evaluate the effects of three class-sparing ART regimens on lipids and lipoproteins. METHODS: This was a substudy of a prospective, multicenter study treatment-naïve HIV-infected individuals randomly assigned to receive a regimen of nucleoside reverse transcriptase inhibitors (NRTIs) + the non-nucleoside reverse transcriptase inhibitor efavirenz, NRTIs + the protease inhibitor lopinavir/ritonavir, or a NRTI-sparing regimen of efavirenz + lopinavir/ritonavir. Lipoproteins were measured by nuclear magnetic resonance spectroscopy. RESULTS: Among the 82 participants, total and small low-density lipoprotein concentrations increased (median, interquartile range) by 152 (-49 - +407, p0.01) and 130 (-98 - +417, p0.01) nmol/L, respectively, especially in the arms containing lopinavir/ritonavir (p(KW)0.04). Very low-density lipoproteins also increased (p0.01), with a larger increase in the arms that contained lopinavir/ritonavir (p=0.022). High-density lipoproteins increased by 6.0 nmol/L (2.8 - 10.4, p0.01), but differences between arms were not significant (p(KW)=0.069). Changes were not related to changes in markers of insulin/glucose metabolism. CONCLUSIONS: Total and small low-density lipoprotein concentrations increased, especially in the arms containing lopinavir/ritonavir, as did increases in total very low-density lipoproteins. Adverse changes were especially prominent in the arm with efavirenz + lopinavir/ritonavir.

Published
2008

161. Efficacy and tolerability of 3 nonnucleoside reverse transcriptase inhibitor-sparing antiretroviral regimens for treatment-naive volunteers infected with HIV-1: a randomized, controlled equivalence trial.

Author

Lennox, Jeffrey L, Lennox, Jeffrey L, Landovitz, Raphael J, Ribaudo, Heather J, Ofotokun, Ighovwerha, Na, Lumine H, Godfrey, Catherine, Kuritzkes, Daniel R, Sagar, Manish, Brown, Todd T, Cohn, Susan E, McComsey, Grace A, Aweeka, Francesca, Fichtenbaum, Carl J, Presti, Rachel M, Koletar, Susan L, Haas, David W, Patterson, Kristine B, Benson, Constance A, Baugh, Bryan P, Leavitt, Randi Y, Rooney, James F, Seekins, Daniel, Currier, Judith S, ACTG A5257 Team, Lennox, Jeffrey L, Lennox, Jeffrey L, Landovitz, Raphael J, Ribaudo, Heather J, Ofotokun, Ighovwerha, Na, Lumine H, Godfrey, Catherine, Kuritzkes, Daniel R, Sagar, Manish, Brown, Todd T, Cohn, Susan E, McComsey, Grace A, Aweeka, Francesca, Fichtenbaum, Carl J, Presti, Rachel M, Koletar, Susan L, Haas, David W, Patterson, Kristine B, Benson, Constance A, Baugh, Bryan P, Leavitt, Randi Y, Rooney, James F, Seekins, Daniel, Currier, Judith S, and ACTG A5257 Team

Abstract

BackgroundNonnucleoside reverse transcriptase inhibitor-based antiretroviral therapy is not suitable for all treatment-naive HIV-infected persons.ObjectiveTo evaluate 3 nonnucleoside reverse transcriptase inhibitor-sparing initial antiretroviral regimens to show equivalence for virologic efficacy and tolerability.DesignA phase 3, open-label study randomized in a 1:1:1 ratio with follow-up for at least 96 weeks. (ClinicalTrials.gov: NCT00811954).Setting57 sites in the United States and Puerto Rico.PatientsTreatment-naive persons aged 18 years or older with HIV-1 RNA levels greater than 1000 copies/mL without resistance to nucleoside reverse transcriptase inhibitors or protease inhibitors.InterventionAtazanavir, 300 mg/d, with ritonavir, 100 mg/d; raltegravir, 400 mg twice daily; or darunavir, 800 mg/d, with ritonavir, 100 mg/d, plus combination emtricitabine, 200 mg/d, and tenofovir disoproxil fumarate, 300 mg/d.MeasurementsVirologic failure, defined as a confirmed HIV-1 RNA level greater than 1000 copies/mL at or after 16 weeks and before 24 weeks or greater than 200 copies/mL at or after 24 weeks, and tolerability failure, defined as discontinuation of atazanavir, raltegravir, or darunavir for toxicity. A secondary end point was a combination of virologic efficacy and tolerability.ResultsAmong 1809 participants, all pairwise comparisons of incidence of virologic failure over 96 weeks showed equivalence within a margin of equivalence defined as -10% to 10%. Raltegravir and ritonavir-boosted darunavir were equivalent for tolerability, whereas ritonavir-boosted atazanavir resulted in a 12.7% and 9.2% higher incidence of tolerability discontinuation than raltegravir and ritonavir-boosted darunavir, respectively, primarily because of hyperbilirubinemia. For combined virologic efficacy and tolerability, ritonavir-boosted darunavir was superior to ritonavir-boosted atazanavir, and raltegravir was superior to both protease inhibitors. Antiretroviral resistance at the time

Published
2014

162. Efficacy and Tolerability of 3 Nonnucleoside Reverse Transcriptase Inhibitor–Sparing Antiretroviral Regimens for Treatment-Naive Volunteers Infected With HIV-1

Author

Lennox, Jeffrey L., primary, Landovitz, Raphael J., additional, Ribaudo, Heather J., additional, Ofotokun, Ighovwerha, additional, Na, Lumine H., additional, Godfrey, Catherine, additional, Kuritzkes, Daniel R., additional, Sagar, Manish, additional, Brown, Todd T., additional, Cohn, Susan E., additional, McComsey, Grace A., additional, Aweeka, Francesca, additional, Fichtenbaum, Carl J., additional, Presti, Rachel M., additional, Koletar, Susan L., additional, Haas, David W., additional, Patterson, Kristine B., additional, Benson, Constance A., additional, Baugh, Bryan P., additional, Leavitt, Randi Y., additional, Rooney, James F., additional, Seekins, Daniel, additional, and Currier, Judith S., additional

Published
2014
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165. EFFICACY AND COMPLEMENTARITY OF HIV-1 SUPPRESSION BY CD4- BINDING bNAbs.

Author

Helmold Hait, Sabrina, Shrader, Hannah, Lovelace, Sarah, Coates, Emily, Rothwell, Ro Shauna, Donaghy, Eileen, Fichtenbaum, Carl J., Santana, Jorge, Presti, Rachel, Roa, Jhoanna, Bhatnagar, Anjali, Lynch, Rebecca M., Tebas, Pablo, Mascola, John R., and Pegu, Amarendra

Published
2023

169. Comparison of Cardiovascular Disease Risk Markers in HIV-Infected Patients Receiving Abacavir and Tenofovir: The Nucleoside Inflammation, Coagulation and Endothelial Function (Nice) Study

Author

Wohl, David A, primary, Arnoczy, Gretchen, additional, Fichtenbaum, Carl J, additional, Campbell, Thomas, additional, Taiwo, Babafemi, additional, Hicks, Charles, additional, McComsey, Grace A, additional, Koletar, Susan, additional, Sax, Paul, additional, Tebas, Pablo, additional, Ha, Belinda, additional, Massengale, Kelly, additional, Walsh, Kendall, additional, and Stein, James H, additional

Published
2013
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170. Prevalence of Diagnosed and Undiagnosed Hepatitis C in a Midwestern Urban Emergency Department.

Author

Lyons, Michael S., Kunnathur, Vidhya A., Rouster, Susan D., Hart, Kimberly W., Sperling, Matthew I., Fichtenbaum, Carl J., and Sherman, Kenneth E.

Subjects
HEPATITIS C diagnosis, MEDICAL screening, EMERGENCY medicine, DISEASE prevalence, PUBLIC health
Abstract

Background. Targeted hepatitis C virus (HCV) screening is recommended. Implementation of screening in emergency department (ED) settings is challenging and controversial. Understanding HCV epidemiology in EDs could motivate and guide screening efforts. We characterized the prevalence of diagnosed and undiagnosed HCV in a Midwestern, urban ED. Methods. This was a cross-sectional seroprevalence study using de-identified blood samples and self-reported health information obtained from consecutively approached ED patients aged 18-64 years. Subjects consented to a "study of diseases of public health importance" and were compensated for participation. The Biochain ELISA kit for Human Hepatitis C Virus was used for antibody assay. Viral RNA was isolated using the Qiagen QIAamp UltraSens Virus kit, followed by real-time reverse transcription polymerase chain reaction using a Bio-Rad CFX96 SYBR Green UltraFast program with melt-curve analysis. Results. HCV antibody was detected in 128 of 924 (14%; 95% confidence interval [CI], 12%-16%) samples. Of these, 44 (34%) self-reported a history of HCV or hepatitis of unknown type and 103 (81%; 95% CI, 73%-87%) were RNA positive. Two additional patients were antibody negative but RNA positive. Fully implemented birth cohort screening for HCV antibody would have missed 36 of 128 (28%) of cases with detectable antibody and 26 of 105 (25%) of those with replicative HCV infection. Conclusions. HCV infection is highly prevalent in EDs. Emergency departments are likely to be uniquely important for HCV screening, and logistical challenges to ED screening should be overcome. Birth cohort screening would have missed many patients, suggesting the need for complementary screening strategies applied to an expanded age range. [ABSTRACT FROM AUTHOR]

Published
2016
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171. Reply to Chu et al.

Author

Zhang, Bin, Huaman, Moises A, Fichtenbaum, Carl J, and Longenecker, Chris T

Subjects
TUBERCULOSIS complications, CARDIOVASCULAR diseases risk factors, CORONARY artery disease, DISEASE risk factors
Abstract

The article addresses question about the odds ratio for obstructive coronary artery disease (OCAD) between participants with and without latent tuberculosis infection (LTBI) that increased from 3.2 in the unadjusted model to 4.96 in the adjusted model. Topics include independent variables are LTBI and atherosclerotic cardiovascular disease (ASCVD) risk score; and ASCVD risk score and LTBI status is also the best model after model selection using the Akaike information criterion.

Published
2022
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173. Changes in Fat Mitochondrial DNA and Function in Subjects Randomized to Abacavir-Lamivudine or Tenofovir DF–Emtricitabine With Atazanavir-Ritonavir or Efavirenz: AIDS Clinical Trials Group Study A5224s, Substudy of A5202

Author

McComsey, Grace A., primary, Daar, Eric S., additional, O'Riordan, MaryAnn, additional, Collier, Ann C., additional, Kosmiski, Lisa, additional, Santana, Jorge L., additional, Fichtenbaum, Carl J., additional, Fink, Heidi, additional, Sax, Paul E., additional, Libutti, Daniel E., additional, and Gerschenson, Mariana, additional

Published
2012
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179. Phase 2a Study of the CCR5 Monoclonal Antibody PRO 140 Administered Intravenously to HIV-Infected Adults

Author

Jacobson, Jeffrey M., primary, Lalezari, Jacob P., additional, Thompson, Melanie A., additional, Fichtenbaum, Carl J., additional, Saag, Michael S., additional, Zingman, Barry S., additional, D'Ambrosio, Paul, additional, Stambler, Nancy, additional, Rotshteyn, Yakov, additional, Marozsan, Andre J., additional, Maddon, Paul J., additional, Morris, Stephen A., additional, and Olson, William C., additional

Published
2010
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181. The importance of methods for site performance evaluation in REPRIEVE, a longitudinal, global, multicenter trial.

Author

Fulda, Evelynne S., Fichtenbaum, Carl J., Kileel, Emma M., Zanni, Markella V., Aberg, Judith A., Malvestutto, Carlos, Cardoso, Sandra Wagner, Berzins, Baiba, Lira, Rita, Harden, Regina, Robbins, Gregory, Martinez, Maria, Nieves, Sylvia Davila, McCallum, Sara, Cruz, Jorge Leon, Umbleja, Triin, Sprenger, Heather, Giguel, Francoise, Bone, Frederic, and Wood, Ken

Subjects
*DATA management, *TELECOMMUNICATION systems, *HIV, *DATA integrity, *HIV-positive persons, *CLINICAL trials
Abstract

REPRIEVE, the Randomized Trial to Prevent Vascular Events in HIV, is a multicenter, primary prevention trial evaluating whether a statin can prevent major cardiovascular events in people with HIV. REPRIEVE is conducted at >100 clinical research sites (CRSs) globally. Detailed, comprehensive, and novel methods for evaluating and communicating CRS performance are required to ensure trial integrity and data quality. In this analysis we describe a comprehensive multidimensional methodology for evaluating CRS performance. The REPRIEVE Data Coordinating and Clinical Coordinating Centers developed a robust system for evaluation of and communication with CRSs, designed to identify potential issues and obstacles to performance, provide real-time technical support, and make recommendations for process improvements to facilitate efficient trial execution. We describe these systems and evaluate their impact on participant retention, data management, and specimen management from 2019 to 2022, corresponding to the period from end of recruitment to present. This evaluation was based on pre-defined metrics, regular reviews, and bidirectional communication. Participant retention, data management, and specimen management all remained steady over the three-year period, although metrics varied by country of enrollment. Targeted messaging relating to certain performance metrics was effective. Site performance is vital to ensure trial integrity and achievement of key trial goals. This analysis demonstrates that utilization of a comprehensive approach allows for a thorough evaluation of CRS performance, facilitates data and specimen management, and enhances participant retention. Our approach may serve as a guidepost for maximizing future large-scale clinical trials' operational success and scientific rigor. ClinicalTrials.gov Identifier: NCT02344290 [ABSTRACT FROM AUTHOR]

Published
2023
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184. Abstract 1248.5: Lipoprotein Changes in HIV-Infected Antiretroviral-Naïve Individuals after Starting Class-Sparing Antiretroviral Therapy: ACTG Study A5152s

Author

Stein, James H, primary, Komarow, Lauren, additional, Cotter, Bruno R, additional, Currier, Judith S, additional, Dube, Michael P, additional, Fichtenbaum, Carl J, additional, Gerschenson, Mariana, additional, Mitchell, Carol K, additional, Murphy, Robert L, additional, Squires, Kathleen, additional, Parker, Robert A, additional, and Torriani, Francesca J, additional

Published
2008
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185. Endothelial Function in Human Immunodeficiency Virus-Infected Antiretroviral-Naive Subjects Before and After Starting Potent Antiretroviral Therapy

Author

Torriani, Francesca J., primary, Komarow, Lauren, additional, Parker, Robert A., additional, Cotter, Bruno R., additional, Currier, Judith S., additional, Dubé, Michael P., additional, Fichtenbaum, Carl J., additional, Gerschenson, Mariana, additional, Mitchell, Carol K.C., additional, Murphy, Robert L., additional, Squires, Kathleen, additional, and Stein, James H., additional

Published
2008
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187. Fish Oil and Fenofibrate for the Treatment of Hypertriglyceridemia in HIV-Infected Subjects on Antiretroviral Therapy

Author

Gerber, John G, primary, Kitch, Douglas W, additional, Fichtenbaum, Carl J, additional, Zackin, Robert A, additional, Charles, Stéphannie, additional, Hogg, Evelyn, additional, Acosta, Edward P, additional, Connick, Elizabeth, additional, Wohl, David, additional, Kojic, E Milu, additional, Benson, Constance A, additional, and Aberg, Judith A, additional

Published
2008
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189. Extended-Release Niacin Versus Fenofibrate in HIV-Infected Participants With Low High- Density Lipoprotein Cholesterol: Effects on Endothelial Function, Lipoproteins, and Inflammation.

Author

Dubé, Michael P., Komarow, Lauren, Fichtenbaum, Carl J., Cadden, Joseph J., Overton, Edgar T., Hodis, Howard N., Currier, Judith S., and Stein, James H.

Subjects
HIV infections, THERAPEUTICS, CARDIOVASCULAR diseases risk factors, HIGH density lipoproteins, NIACIN, FENOFIBRATE, CHOLESTEROL, ENDOTHELIAL cells, INFLAMMATION
Abstract

Background. Low levels of high-density lipoprotein cholesterol (HDL-C) are common in individuals with human immunodeficiency virus (HIV) infection, persist during antiretroviral therapy (ART), and are associated with increased cardiovascular disease (CVD) risk. Methods. Virologically controlled participants without CVD on stable ART with low HDL-C (men <40 mg/dL, women <50 mg/dL) and triglycerides >150 mg/dL were randomized to receive open-label extended-release niacin 1500 mg/day with aspirin 325 mg/day or fenofibrate 200 mg/day for 24 weeks. The primary endpoint was the week 24 within-arm change in brachial artery flow-mediated dilation (FMD) in participants with complete follow-up scans. Results. Of 99 participants, 74 had complete data (35 niacin, 39 fenofibrate). Median age was 45 years, 77% were male, median CD4+ count was 561 cells/µL, and brachial FMD was 4.2%. Median HDL-C was 32 mg/dL for men and 38 mg/dL for women, low-density lipoprotein cholesterol was 103 mg/dL, and triglycerides were 232 mg/dL. In men, HDL-C increased a median of 3 mg/dL with niacin and 6.5 mg/dL with fenofibrate (P < .001 for both). In women, HDL-C increased a median of 16 mg/dL with niacin and 8 mg/dL with fenofibrate (P = .08 for both). After 24 weeks, there was no significant change in FMD in either arm; the median (interquartile range) change was +0.6% (-1.6 to 2.3) with niacin (P = .28) and +0.5% (-1.0 to 3.0) with fenofibrate (P = .19). Neither treatment significantly affected C-reactive protein, interleukin 6, or D-dimer levels. Conclusions. Despite improvements in lipids, niacin or fenofibrate treatment for 24 weeks did not improve endothelial function or inflammatory markers in participants with well-controlled HIV infection and low HDL-C. [ABSTRACT FROM AUTHOR]

Published
2015
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190. A Randomized Trial of the Efficacy and Safety of Fenofibrate versus Pravastatin in HIV-Infected Subjects with Lipid Abnormalities: AIDS Clinical Trials Group Study 5087

Author

Aberg, Judith A., primary, Zackin, Robert A., additional, Brobst, Susan W., additional, Evans, Scott R., additional, Alston, Beverly L., additional, Henry, W. Keith, additional, Glesby, Marshall J., additional, Torriani, Francesca J., additional, Yang, Yijun, additional, Owens, Susan I., additional, and Fichtenbaum, Carl J., additional

Published
2005
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191. Comparison of Two Indinavir/Ritonavir Regimens in the Treatment of HIV-Infected Individuals

Author

Acosta, Edward P, primary, Wu, Hulin, additional, Hammer, Scott M, additional, Yu, Song, additional, Kuritzkes, Daniel R, additional, Walawander, Ann, additional, Eron, Joseph J, additional, Fichtenbaum, Carl J, additional, Pettinelli, Carla, additional, Neath, Denise, additional, Ferguson, Elaine, additional, Saah, Alfred J, additional, and Gerber, John G, additional

Published
2004
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200. Refractory Mucosal Candidiasis in Advanced Human Immunodeficiency Virus Infection

Author

Fichtenbaum, Carl J., primary, Koletar, Susan, additional, Yiannoutsos, Constantin, additional, Holland, Fiona, additional, Pottage, John, additional, Cohn, Susan E., additional, Walawander, Ann, additional, Frame, Peter, additional, Feinberg, Judith, additional, Saag, Michael, additional, Van der Horst, Charles, additional, and Powderly, William G., additional

Published
2000
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