Preventing Sexual Transmission of HIV With Anti-HIV Drugs
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Atazanavir; Didanosine; Efavirenz; Emtricitabine/Tenofovir disoproxil fumarate; Lamivudine; Lopinavir/Ritonavir; Nevirapine; Stavudine; Tenofovir disoproxil fumarate; Zidovudine/Lamivudine
Intervention description: 300 mg taken orally once daily; 400 mg taken orally once daily; 600 mg taken orally once daily; 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily; 300 mg taken orally once daily; 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily; 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily; Dosage depends on weight; 300 mg taken orally once daily; 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily
Intervention MeSH terms: Ritonavir; Lopinavir; Atazanavir Sulfate; Tenofovir; Lamivudine; Emtricitabine; Zidovudine; Nevirapine; Stavudine; Didanosine; Efavirenz
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 3526.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV Infections; HIV Seronegativity

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.
    

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