A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care Versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples

Date de début de l'étude : 1 février 2005

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