The Terry Beirn CPCRA Clinical Trials Unit is composed of investigators and research staff at 7 Clinical Research Sites with over 20 years of experience in HIV, hepatitis, tuberculosis and prevention research and patient care and with an established record of effective and efficient collaboration over the past 6 years. The CPCRA CTU aims to conduct clinically relevant research in the prevention and treatment of HIV, hepatitis, and tuberculosis; to enroll a demographically, geographically, and socio-economically diverse population of individuals into clinical trials; and to carry out this research agenda in clse collaboration with community members who are themselves affected by HIV, hepatitis, or tuberculosis. The Terry Beirn CPCRA CTU will make significant contributions to the ACTG and HPTN leadership groups, both in enrollment and in scientific expertise. Through the ACTG, the CPCRA CTU will contribute to multiple, randomized clinical trials in strategies to cure and/or achieve functional cure of HIV, studies to improve the diagnosis and treatment of tuberculosis, strategies to cure infectious hepatitis, and strategies to improve the treatment of, or prevent, non-infectious co-morbidities and evaluate novel therapeutic interventions targeting HIV infection. Through the HPTN, the CPCRA CTU will evaluate and optimize integrated strategies to prevent HIV infection, and evaluate and optimize the most promising pre-exposure prophylaxis (PrEP) regimens. Targeted populations include those who are H1V+ as well as those who are HIV- and at-risk for seroconversion, especially high-risk subgroups. The Administrative Office of the CPCRA CTU located at the Veterans Affairs Medical Center in Washington, DC, is an off-campus affiliate of the applicant organization, the George Washington University. The CTU Principal Investigator and Administrative Office staff provide oversight, coordination, training, technical assistance and regulatory support for 7 Clinical Research Sites, 6 affiliated with the ACTG (Denver Public Health, Henry Ford Hospital, Houston AIDS Research Team, Virginia Commonwealth University, Wayne State University) and 1 with HPTN (George Washington University).
Ongoing research on prevention and treatment of HIV, tuberculosis and hepatitis is imperative given the continued prevalence of these global infections. Investigators affiliated with the Terry Beirn CPCRA CTU and its 7 Clinical Research Sites are experienced, competent, and committed to make significant contributions to reduce the burden of these infections on people's lives.
|MacBrayne, Christine E; Marks, Kristen M; Fierer, Daniel S et al. (2018) Effects of sofosbuvir-based hepatitis C treatment on the pharmacokinetics of tenofovir in HIV/HCV-coinfected individuals receiving tenofovir disoproxil fumarate. J Antimicrob Chemother 73:2112-2119|
|Tracy, LaRee A; Struble, Kimberly; Firnhaber, Cynthia et al. (2018) Age Differences by Sex in Antiretroviral-Naïve Participants: Pooled Analysis from Randomized Clinical Trials. J Assoc Nurses AIDS Care 29:371-382|
|Riddler, Sharon A; Zheng, Lu; Durand, Christine M et al. (2018) Randomized Clinical Trial to Assess the Impact of the Broadly Neutralizing HIV-1 Monoclonal Antibody VRC01 on HIV-1 Persistence in Individuals on Effective ART. Open Forum Infect Dis 5:ofy242|
|Kalayjian, Robert C; Albert, Jeffrey M; Cremers, Serge et al. (2018) Women have enhanced bone loss associated with phosphaturia and CD4+ cell restoration during initial antiretroviral therapy. AIDS 32:2517-2524|
|Gulick, Roy M; Wilkin, Timothy J; Chen, Ying Q et al. (2017) Safety and Tolerability of Maraviroc-Containing Regimens to Prevent HIV Infection in Women: A Phase 2 Randomized Trial. Ann Intern Med 167:384-393|
|Levy, M E; Greenberg, A E; Hart, R et al. (2017) High burden of metabolic comorbidities in a citywide cohort of HIV outpatients: evolving health care needs of people aging with HIV in Washington, DC. HIV Med 18:724-735|
|Gulick, Roy M; Wilkin, Timothy J; Chen, Ying Q et al. (2017) Phase 2 Study of the Safety and Tolerability of Maraviroc-Containing Regimens to Prevent HIV Infection in Men Who Have Sex With Men (HPTN 069/ACTG A5305). J Infect Dis 215:238-246|
|Kiser, Jennifer J; Lu, Darlene; Rosenkranz, Susan L et al. (2017) Boceprevir and Antiretroviral Pharmacokinetic Interactions in HIV/HCV Co-infected Persons: AIDS Clinical Trials Group Study A5309s. Drugs R D 17:557-567|
|Golin, Carol E; Haley, Danielle F; Wang, Jing et al. (2016) Post-traumatic Stress Disorder Symptoms and Mental Health over Time among Low-Income Women at Increased Risk of HIV in the U.S. J Health Care Poor Underserved 27:891-910|
|Robbins, Gregory K; Cohn, Susan E; Harrison, Linda J et al. (2016) Characteristics associated with virologic failure in high-risk HIV-positive participants with prior failure: a post hoc analysis of ACTG 5251. HIV Clin Trials 17:165-72|
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