Preventing Sexual Transmission of HIV With Anti-HIV Drugs
- Conditions
- HIV Infections
- Interventions
- Registration Number
- NCT00074581
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3526
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Zidovudine/Lamivudine Participants will begin ART in addition to receiving HIV primary care 1 Emtricitabine/Tenofovir disoproxil fumarate Participants will begin ART in addition to receiving HIV primary care 1 Lopinavir/Ritonavir Participants will begin ART in addition to receiving HIV primary care 2 Zidovudine/Lamivudine 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. 2 Lopinavir/Ritonavir 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. 2 Emtricitabine/Tenofovir disoproxil fumarate 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. 1 Tenofovir disoproxil fumarate Participants will begin ART in addition to receiving HIV primary care 1 Atazanavir Participants will begin ART in addition to receiving HIV primary care 1 Didanosine Participants will begin ART in addition to receiving HIV primary care 1 Lamivudine Participants will begin ART in addition to receiving HIV primary care 1 Efavirenz Participants will begin ART in addition to receiving HIV primary care 1 Nevirapine Participants will begin ART in addition to receiving HIV primary care 1 Stavudine Participants will begin ART in addition to receiving HIV primary care 2 Atazanavir 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. 2 Didanosine 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. 2 Efavirenz 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. 2 Lamivudine 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. 2 Nevirapine 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. 2 Stavudine 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. 2 Tenofovir disoproxil fumarate 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.
- Primary Outcome Measures
Name Time Method All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms Throughout study All Incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm.
Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms Throughout study incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm. Only acquisition from the index partner were included in the primary analysis, therefore, each endpoint was required to be confirmed (by genotyping) such that the viral envelop sequence in the index case matched that of the partner.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
Fenway Community Health Ctr. CRS
🇺🇸Boston, Massachusetts, United States
Gaborone CRS
🇧🇼Gaborone, Botswana
Hospital Geral de Nova Iguaçu CRS (HGNI CRS)
🇧🇷Nova Iguacu, Rio De Janeiro, Brazil
Hospital Nossa Senhora da Conceicao CRS
🇧🇷Port Alegre, Rio Grande Do Sul, Brazil
HSE-Hospital dos Servidores do Estado CRS
🇧🇷Rio de Janeiro, Brazil
NARI Clinic at NIV CRS
🇮🇳Pune, Maharashtra, India
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
🇧🇷Rio de Janeiro, Brazil
NARI Clinic at Gadikhana Dr. Kotnis Municipal Dispensary CRS
🇮🇳Pune, Maharashtra, India
NARI Pune CRS
🇮🇳Pune, Maharashtra, India
Chennai Antiviral Research and Treatment (CART) CRS
🇮🇳Chennai, Tamil Nadu, India
Kisumu Crs
🇰🇪Kisumu, Nyanza, Kenya
Blantyre CRS
🇲🇼Blantyre, Malawi
Malawi CRS
🇲🇼Lilongwe, Malawi
Soweto HPTN CRS
🇿🇦Johannesburg, Gauteng, South Africa
Wits Helen Joseph Hospital CRS (Wits HJH CRS)
🇿🇦Johannesburg, Gauteng, South Africa
CMU HIV Prevention CRS
🇹🇭Chiang Mai, Thailand
Parirenyatwa CRS
🇿🇼Harare, Zimbabwe