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.

Condition	Treatment or Intervention	Phase
HIV Infections HIV Seronegativity	Drug: Zidovudine/Lamivudine  Drug: Nevirapine  Drug: Tenofovir disoproxil fumarate  Drug: Atazanavir  Drug: Efavirenz  Drug: Didanosine, enteric coated  Drug: Stavudine  Drug: Lamivudine	Phase III

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 if initiating ART in ART-naive, HIV infected people can prevent the sexual transmission of HIV among HIV-discordant couples. 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 87 months (7 years, 3 months). 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 only. 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 sexual history and adherence to the ART regimen.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria for HIV Infected Partner:

• Positive HIV test within 60 days of study entry
• CD4 cell count between 300 and 500 cells/mm3 within 30 days of study entry

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 3 times in the last 3 months
• If pregnant or breastfeeding, is willing to be assigned to either arm of study
• Agrees to use acceptable forms of contraception
• 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 HIV antiretroviral therapy (ART). Previous short-term use of ART for prevention of mother-to-child transmission of HIV is 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
• Pregnancy. Breastfeeding is allowed at enrollment; however, during the initial enrollment period, women may not be on a regimen containing study-provided atazanavir if they are breastfeeding.

Exclusion Criteria for Both Partners:

• History of injection drug use within 5 years of study entry
• Receipt of an experimental HIV vaccine
• 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

Study chairs or principal investigators

Myron S. Cohen, MD,  Study Chair,  University of North Carolina   

Study ID Numbers:  HPTN 052
Record last reviewed:  October 2004
Record first received:  December 16, 2003
ClinicalTrials.gov Identifier:  NCT00074581
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-08