Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Nevirapine; Nevirapine placebo
Intervention description: 10 mg/ml oral suspension taken once daily up to 6 months of age. Dosage will increase throughout study.; Oral suspension taken once daily up to 6 months of age
Intervention MeSH terms: Nevirapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 2026.0
Sex: All
Healthy volunteers: No
Keywords: HIV Seronegativity; Treatment Experienced; Treatment Naive

Summary:

      The many benefits of breastfeeding are well documented. However, because of the risk of
      mother-to-child transmission (MTCT) of HIV from an HIV infected mother to her infant, there
      is considerable concern over the practice, especially in developing countries. The purpose of
      this study is to determine the safety and effectiveness of the anti-HIV drug nevirapine (NVP)
      in preventing MTCT of HIV in breastfeeding infants born to HIV infected women in South
      Africa, Tanzania, Uganda, and Zimbabwe.
    

Eligibility criteria:

        Note: As of 08/10/07, the arm assignments for current and new participants have changed.
        Please see the above description for this trial for more information.

        Inclusion Criteria for Mothers:

          -  18 years of age or older

          -  HIV infected

          -  In third trimester of pregnancy, or at most 3 days post-delivery

          -  If baby is not yet born, planning to deliver at a facility where the study is being
             conducted

          -  Plan to breastfeed

        Exclusion Criteria for Mothers:

          -  Complications with this pregnancy

          -  Serious medical condition that would interfere with the study (e.g., that would
             prevent breastfeeding or adherence to the follow-up schedule), as judged by the
             on-site clinician

        Inclusion Criteria for Infants:

          -  Born to an HIV infected mother who is eligible for the study

          -  Weighed at least 2000 grams (4.4 lbs) at birth

          -  Blood sample obtained from the infant for HIV-1 DNA PCR, CBC with differential, and
             ALT

          -  Infants in a multiple birth are eligible only if both/all infants are eligible for the
             study and assigned to the same study group

          -  Able to breastfeed (e.g., mother and infant alive with no condition apparent that
             would prevent breastfeeding)

        Exclusion Criteria for Infants:

          -  HIV DNA PCR positive at birth

          -  ALT of Grade 2 or higher at birth

          -  Hemoglobin, absolute neutrophil count, or platelet count of Grade 3 or higher at birth

          -  Skin rash of Grade 2B (urticaria), Grade 3, or above

          -  Confirmed or suspected clinical hepatitis

          -  Serious illness or condition that would interfere with compliance with study
             procedures