A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples
Sponsors:
Division of AIDS, US National Institute of Allergy and Infectious Diseases (NIAD)
National Institutes of Health (NIH)
Protocol Summary:
HPTN 052 is a phase III, two-arm, randomized, controlled, multi-center study that aims to determine if antiretroviral therapy (ARV) can prevent sexual transmission of HIV-1 in HIV-1 serodiscordant couples. Couples were assigned to one of two study arms: 1) immediate initiation of ART in the HIV-infected partner upon enrollment, or 2) delayed initiation of ART in the HIV-infected partner until two consecutive CD4 cell counts were at or below 250 cells/mm3 or an AIDS-defining illness developed.
Years: 2007 – 2015
Investigator: James Hakim, MBChB, FRCP
Location: Parirenyatwa CRS
Publication: Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, et al. (2011) Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 365(6): 493-505.
HPTN
Completed Study
Publication:
Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, et al. (2011) Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 365(6): 493-505.
Grinsztejn B, Hosseinipour MC, Ribaudo HJ, et al. (2014) Effects of early versus delayed initiation of antiretroviral treatment on clinical outcomes of HIV-1 infection: results from the phase 3 HPTN 052 randomised controlled trial. Lancet Infect Dis. 2014 Apr; 14(4):281-90.
Fogel JM, Hudelson SE, Ou SS, et al. (2016) Brief Report: HIV Drug Resistance in Adults Failing Early Antiretroviral Treatment: Results from the HIV Prevention Trials Network 052 Trial. J Acquir Immune Defic Syndr. 2016 July 1, 72(3): 304-9.
Eshleman SH, Hudelson SE, Redd AD, et al. (2017) Treatment as Prevention: Characterization of Partner Invections in the HIV Prevention Trials Network 082 Trial. J Acquir Immune Defic Syndr. 2017 Jan 1; 74(1): 112-116.
Eshleman SH, Wilson EA, Zhang XC, et al. (2017) Virologic outcomes in early antiretrovial treatment: HPTN 052. HIV Clin Trials. 2017 Apr 7: 1-10.
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