Preventing Sexual Transmission of HIV With Anti-HIV Drugs
HIV Infections

About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV Infections, HIV Seronegativity
Eligibility Criteria
Inclusion Criteria for HIV Infected Partner: Positive HIV test within 60 days of study entry CD4 count between 350 and 550 cells/mm3 within 30 days of study entry If pregnant or breastfeeding, willing to be randomized to either arm of the study Inclusion Criteria for HIV Uninfected Partner: Negative HIV test within 14 days of study entry Inclusion Criteria for Both Partners: Plans to maintain sexual relationship with partner Reports having sex (vaginal or anal) with partner at least three times in the last 3 months Willing to disclose HIV test results to partner Plans to stay in the area and does not have a job or other obligations that may require long absences during the duration of the study Exclusion Criteria for HIV Infected Partner: Current or previous use of any ART. Participants who previously took a short-term course of ART for prevention of mother-to-child transmission of HIV are not excluded. Documented or suspected acute hepatitis within 30 days of study entry, if the infected partner's starting regimen in the study contains nevirapine or atazanavir Current or previous AIDS-defining illness or opportunistic infection Documented or suspected acute hepatitis within 30 days prior to study entry Acute therapy of serious medical illnesses within 14 days prior to study entry Radiation therapy or systemic chemotherapy within 45 days prior to study entry Immunomodulatory or investigational therapy within 30 days prior to study entry Active drug or alcohol dependence that, in the opinion of the investigator, would interfere with the study Vomiting or inability to swallow medications Require certain medications Allergy or sensitivity to any of the study drugs Exclusion Criteria for Both Partners: History of injection drug use within 5 years of study entry Previous and/or current participation in an HIV vaccine study Currently detained in jail or for treatment of a psychiatric or physical illness Any condition that, in the opinion of the study staff, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives Certain abnormal laboratory values
Sites / Locations
- Fenway Community Health Ctr. CRS
- Gaborone CRS
- Hospital Geral de Nova Iguaçu CRS (HGNI CRS)
- Hospital Nossa Senhora da Conceicao CRS
- HSE-Hospital dos Servidores do Estado CRS
- Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
- NARI Clinic at Gadikhana Dr. Kotnis Municipal Dispensary CRS
- NARI Clinic at NIV CRS
- NARI Pune CRS
- Chennai Antiviral Research and Treatment (CART) CRS
- Kisumu Crs
- Blantyre CRS
- Malawi CRS
- Soweto HPTN CRS
- Wits Helen Joseph Hospital CRS (Wits HJH CRS)
- CMU HIV Prevention CRS
- Parirenyatwa CRS
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
1
2
Participants will begin ART in addition to receiving HIV primary care
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.