Clinical trial NCT00074581
Conditions: HIV Infections
Keywords: HIV Infections HIV Seronegativity
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Start date: 2005-02-01; Completion date: 2015-05-01
Enrollment: 3526 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.

Detailed description:
Initiation of antiretroviral therapy (ART) in the HIV infected population has been shown to dramatically reduce the morbidity and mortality of HIV infection through sustained reduction in HIV viral replication. However, such therapy does not cure HIV infection or prevent the spread of the virus. ART may, however, make HIV infected people less contagious by lowering plasma HIV-1 RNA levels, compared with people not on ART. 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: 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.

Arms: arm 1: Participants will begin ART in addition to receiving HIV primary care 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.
Interventions: intervention 1: Atazanavir intervention 2: Didanosine intervention 3: Efavirenz intervention 4: Emtricitabine/Tenofovir disoproxil fumarate intervention 5: Lamivudine intervention 6: Lopinavir/Ritonavir intervention 7: Nevirapine intervention 8: Stavudine intervention 9: Tenofovir disoproxil fumarate intervention 10: Zidovudine/Lamivudine
Intervention descriptions: intervention 1: 300 mg taken orally once daily intervention 2: 400 mg taken orally once daily intervention 3: 600 mg taken orally once daily intervention 4: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily intervention 5: 300 mg taken orally once daily intervention 6: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily intervention 7: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily intervention 8: Dosage depends on weight intervention 9: 300 mg taken orally once daily intervention 10: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily

Protocol documents: