Email Updates

Search form

You are here

HPTN 052

Status
Completed
Phase
III
Principal Investigator(s)
Myron S. Cohen, MD - University of North Carolina, Chapel Hill
Objective

This study seeks to determine whether initiating ART in ART-naive, HIV infected people can prevent the sexual transmission of HIV among HIV-discordant couples, as well as to demonstrate whether quality of life changes with the initiation of ART. Both opposite and same sex couples will be recruited at study sites in Brazil, India, Malawi, Thailand, the United States, and Zimbabwe for this study. Participating couples will be enrolled for approximately 78 months (6.5 years). Couples will be randomly assigned to one of two arms. HIV infected partners in Arm 1 will begin ART in addition to receiving HIV primary care. HIV infected partners in Arm 2 will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART. All couples will receive HIV counseling and have their urine and blood collected at screening and enrollment, and at selected monthly, quarterly, and yearly intervals. They will be asked to periodically report information about their adherence to the ART regimen.


Note: As of May 10, 2011 per  the Data and Safety and Monitoring Board (DSMB) recommendation all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible.

Prevention Option(s)
Treatment
Study Design
Controlled
Randomized
Arms and Assigned Interventions
Description
Arm 1: Participants will begin ART in addition to receiving HIV primary care.
Mode of Delivery
Tablet
Products
Atazanavir
Didanosine
Efavirenz
Lamivudine
Lopinavir/Ritonavir
Nevirapine
Stavudine
TDF
TDF/FTC (Truvada)
Zidovudine/Lamivudine
ARMs
Experimental
Description
Arm 2: Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART. Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible.
Mode of Delivery
Tablet
Products
Atazanavir
Didanosine
Efavirenz
Lamivudine
Lopinavir/Ritonavir
Nevirapine
Stavudine
TDF
TDF/FTC (Truvada)
Zidovudine/Lamivudine
ARMs
Experimental
Trial Sponsors
HPTN, NIAID
February 2005
May 2015
Enrollment
3 500
18
Years
Population
Women
Men
Sites

Fenway Health (FH) CRS

Boston, Massachusetts
United States of America

Gaborone Prevention/Treatment Trials CRS

Gaborone
Botswana

Hospital Geral de Nova Iguaçu

Nova Iguacu, Rio de Janeiro
Brazil

Hospital Nossa Senhora da Conceicao

Port Alegre, Rio Grande do Sul
Brazil

Instituto de Pesquisa Clínica Evandro Chagas

Rio de Janeiro
Brazil

HSE-Hospital dos Servidores do Estado

Rio de Janeiro
Brazil

NARI Clinic at NIV

Pune, Maharashtra
India

NARI Pune

Pune, Maharashtra
India

NARI Clinic at Gadikhana Dr. Kotnis Municipal Dispensary

Pune, Maharashtra
India

YRG CARE Medical Ctr., VHS Chennai

Taramani
India

Kemri/Cdc

Kisumu
Kenya

College of Medicine John Hopkins University Clinical Research Site

Blantyre
Malawi

University of North Carolina - Lilongwe

Lilongwe
Malawi

Soweto HPTN CRS

Johannesburg, Gauteng
South Africa

Wits HIV CRS

Johannesburg, Gauteng
South Africa

Chiang Mai University AIDS Prevention

Chiang Mai
Thailand

UZ-Parirenyatwa

Harare
Zimbabwe