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

Sponsor: Division of AIDS, U.S. National Institute of Allergy and Infectious Diseases, Boehringer-Ingelheim Pharmaceuticals, Inc, Bristol- Myers Squibb, Gilead Sciences, Inc, GlaxoSmithkline and Merck & Co. Inc.

Name of PI:   Professor James G Hakim
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Study Summary

The purpose of this study is to determine whether antiretroviral therapy can prevent sexual transmission of HIV-1 in HIV serodiscordant couples who are adults above the age of eighteen years.

In this Phase 111, two arm, randomized, controlled, multi-cneter trial , 1750 HIV serodiscordant couples in which the HIV- infected partner is ART –naïve and has a CD4+cell count of 350-550cells/mm will be enrolled. HIV-infected index cases will be randomized in a 1:1 ratio to one of two study arms. Those randomized into Arm 1 will receive antiretroviral therapy (ART) plus HIV primary care upon enrolment. Index cases of couples randomized into Arm 2 will receive HIV primary care without initiation of ART until they have two consecutive CD4+ counts within or below the range of 200-250 cells/mm3 or develop an AIDS-defining illness. Enrollment into full study will require 18 months; each participant will be followed for 60 months. The total length of the trial therefore will be 87 months (5years).

In Zimbabwe the study is being conducted at Parirenyatwa Hospital in Harare. The pilot phase of the study was conducted between January 2006 and September 2006. 10 serodiscordant couples were enrolled and followed up. The full study in which 240 serodiscordant couples will be enrolled will commence in September 2007. Follow-up study visits will continue until the last enrolled couple has completed their 60 months in the study.
The following sites will also participate in the study; Blantyre and Lilongwe in Malawi, Chennai and Pune in India, Porto Alegre, Manguinhos, Nova Iguacu and Rio de Janeiro all in Brazil, Gaborone in Botswana, Johannesburg in South Africa, Chiang Mai in Thailand and Boston, Massachusetts in USA.

Latest on 052 

The HPTN 052 Study is closed to accrual all couples are being followed until the last couple enrolled completes thier 60-Month follow-up visit.

Study Contacts

• Dr Nehemiah Nhando-(Senior Research Medical officer)
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• Jimijika Batani-(Study Coordinator)
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