What is HPTN 052?

HPTN 052 is a Phase III, two-arm, multi-site, randomized trial to determine the effectiveness of two treatment strategies in preventing the sexual transmission of HIV in HIV-serodiscordant couples.

Based on data collected in Africa and Thailand, there is a correlation between HIV viral load (blood levels) and HIV transmission.  Specifically, the higher the viral load in the blood, the more likely the chance for transmission.  Antiretroviral therapy (ART) reduces the viral load in the blood, as well as in genital secretions (for both men and women), and the drugs can be detected in semen and vaginal and cervical secretions.  All of this information strongly suggests that ART may make HIV-infected people less contagious.  HPTN 052 compares the HIV‑infection rates of two groups of HIV-serodiscordant couples.  The index case of the first group starts taking ART as soon as the couple is enrolled in the study, while the index case of the second group starts taking ART when he or she has two consecutive measurements of a CD4+ cell count within or below the range of 200-250 cells/mm³, or when he or she develops an AIDS-defining illness.  Both groups will receive HIV primary care and couples counseling sessions to teach them how to reduce their risk of transmission.

Protocol Status: Enrolling

Study Summary

Study Purpose: The purpose of this study is to determine whether antiretroviral therapy (ART) can prevent the sexual transmission of HIV-1 in HIV-1 serodiscordant couples.

Study Design: The study is a Phase III, two-arm, randomized, controlled, multi-center trial.

Study Population: HIV serodiscordant couples in which the HIV-infected partner is ART naïve and has a CD4+ cell count of 350-550 cells/mm^3.

Study Size: Approximately 1750 couples total.

Study Duration: Approximately 78 months total. Accrual will require approximately 18 months total, and all couples will be followed until the last couple enrolled completes their 60-month follow-up visit.

Treatment Regimen: HIV-infected index cases will be assigned at random in a 1:1 ratio to one of two treatment arms: ARM 1: ART upon enrollment plus HIV primary care. ARM 2: HIV primary care without initiation of ART until the participant has two consecutive measurements of a CD4+ cell count within or below the range of 200-250 cells/mm^3, or develops an AIDS-defining illness. The ART drugs available for the study are Combivir [3TC/ZDV], ATV, EFV, NVP, TDF, 3TC, ddI-EC, d4T, Kaletra/Aluvia [LPV/r], and Truvada [FTC/TDF].

Primary Objectives: The primary objective of the study is to compare the rates of HIV infection among partners of HIV-infected participants in the two study arms below: (1) Antiretroviral therapy upon enrollment plus HIV primary care. (2) HIV primary care, without initiation of antiretroviral therapy until the participant has two consecutive measurements of a CD4+ cell count within or below the range of 200-250 cells/mm^3, or develops an AIDS-defining illness.

Secondary Objectives: To determine the long-term safety of two ART regimen strategies (ART immediately upon enrollment vs, ART when the participant has two consecutive measurements of a CD4+ cell count within or below the range of 200-250 cells/mm^3 or develops an AIDS-defining illness) for the treatment of HIV-1 infection. To characterize and compare the patterns and rates of antiretroviral drug resistance of two antiretroviral treatment strategies. To assess factors associated with and to compare adherence of two antiretroviral treatment strategies. To evaluate the usefulness of measures of virologic and immunologic efficacy, and measures to detect antiretroviral drug resistance. To determine, characterize, and compare the rates of AIDS-defining illnesses, sexually transmitted diseases, opportunistic infections, and immune reconstitution syndromes, with regard to outcomes and survival as observed in different geographic settings and by antiretroviral treatment strategies. To determine and characterize the rates of antiretroviral drug-associated toxicities observed in different geographic settings and by treatment strategies. To evaluate the effectiveness of couples HIV counseling and characterize the patterns of sexual behavior in couples in both arms of the study. To characterize and compare Quality of Life (QOL) indicators in different geographic settings and by antiretroviral treatment strategies.

SDMC Protocol Specialist: Leslie Cottle get info

Protocol Co-Chair: Beatriz Grinsztejn get info

Protocol Co-Chair: Breno Riegel Santos get info

Protocol Co-Chair: David DuPuy Celentano get info

Protocol Co-Chair: Irving Hoffman get info

Protocol Co-Chair: James Gita Hakim get info

Protocol Co-Chair: Johnstone Kumwenda get info

Protocol Co-Chair: Karin Alvarenga-Hyldgaard Nielsen get info

Protocol Co-Chair: Kenneth H. Mayer get info

Protocol Co-Chair: Mina Christine Hosseinipour get info

Protocol Co-Chair: Nagalingeshwaran Kumarasamy get info

Protocol Co-Chair: Nancy Padian get info

Protocol Co-Chair: Robert C. Bollinger get info

Protocol Co-Chair: Sheela Godbole get info

Protocol Co-Chair: Suwat Chariyalertsak get info

Protocol Co-Chair: Taha Taha get info

Protocol Chair: Myron Cohen get info

DAIDS Medical Officer: David Burns get info

CORE Protocol Specialist: Jackie Talley get info

CORE Protocol Specialist: Marybeth McCauley get info

CORE Protocol Specialist: Phaedrea Spencer get info

CORE Protocol Specialist: Theresa Gamble get info