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 U=U
Study Design:Controlled, Randomized
Arms and Assigned Interventions
DescriptionArm 1: Participants will begin ART in addition to receiving HIV primary care.
Mode of DeliveryTablet
ARMsExperimental
DescriptionArm 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 DeliveryTablet
ARMsExperimental
Official Code:
NCT00074581
Trial Sponsors:
HPTN, NIAID
Start Date
End Date
February 1, 2005
May 8, 2015
Enrollment:3,500
Age range:
18 Years ↔
any
Population:Cisgender Men, Cisgender Women