| Protocol No: | ECCT/09/06/02 | Date of Protocol: | 20-11-2006 |
| Study Title: |
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
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| Study Objectives: | |
| Laymans Summary: | |
| Abstract of Study: |
Titke: Plus HIV Primary Care versus HIV Primary Care Alone to Prevent the Sexual Transmission of
HIV-1 In Serodiscordant Couples
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.
Design: The study is a Phase III, two-arm, randomized, controlled, multi-center trial. This trial
consists of a run-in period, which has been completed, and a full study.
Study Population: HIV serodiscordant couples in which the HIV-infected partner is ART-naive and
has a CD4+ cell count of 350-550 cells/mm3.
Study Size: Approximately 1750 couples total
Study Arms: 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/mm3, or develops an AIDS-defining illness.
The ART drugs provided through the study include Combivir® [3TC/zidovudine(ZDV)],
efavirenz [EFV], atazanavir [ATV], nevirapine [NVP], tenofovir [TDF], lamivudine [3TC],
didanosine [ddI-EC], stavudine [d4T], Kaletra®/Aluvia® [lopinavir(LPV)/ritonavir (r)], and
Truvada® [emtricitabine (FTC)/tenofovir (TDF)].
Study Duration: The duration of the full study will be approximately 78 months total. Accrual
into the study will require approximately 18 months total, and all couples will be followed until
the last couple enrolled completes their 60-month follow-up visit.
Study 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) ART upon enrollment plus HIV primary care.
(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/mm3,
or develops an AIDS-defining illness.
HPTN 052 Final Version 3.0, 20 November 2006 Page 16 of 173
The secondary objectives of the study are to:
• Determine the long-term safety of two antiretroviral treatment strategies (i.e., immediate
upon enrollment vs. ART initiation when the participant has two consecutive
measurements of a CD4+ cell count within or below the range of 200-250 cells/mm3,
or develops an AIDS-defining illness).
• Characterize and compare the patterns and rates of antiretroviral drug resistance of two
antiretroviral treatment strategies.
• Assess factors associated with adherence and compare the adherence rate of two
antiretroviral treatment strategies.
• Evaluate the usefulness of measures of virologic and immunologic efficacy, and measures
to detect antiretroviral drug resistance.
• 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.
• Determine and characterize the rates of antiretroviral drug-associated toxicities observed
in different geographic settings and by treatment strategies.
• Evaluate the effectiveness of couples HIV counseling and characterize the patterns of
sexual behavior in couples in both arms of the study.
• Characterize and compare Quality-of-Life (QOL) indicators in different geographic
settings and by antiretroviral treatment strategies.
Study Sites:
• Porto Alegre, Brazil
• Rio de Janeiro, Brazil
• Chennai, India
• Pune, India
• Blantyre, Malawi
• Lilongwe, Malawi
• Chiang Mai, Thailand
• Boston, Massachusetts, United States of America
• Harare, Zimbabwe
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