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.

Breastfeeding provides general health, growth, and development benefits to an infant and significantly decreases the risk of certain acute and chronic diseases. Breastfeeding also decreases financial burden on the mother by decreasing the need for infant formula and health care for the infant. However, clinical evidence has shown that HIV can be readily transmitted through breast milk, although the risk of HIV MTCT over time while breastfeeding has been difficult to determine. Given the many advantages of breastfeeding and the significant obstacles to substituting formula for breast milk in developing countries, there is an urgent need to make breastfeeding by HIV infected women safe. This study will evaluate the safety and efficacy of an extended NVP regimen for prevention of MTCT of HIV through breastfeeding.

Mother/infant pairs will be enrolled over a period of 18 to 24 months. During the third trimester of pregnancy, HIV infected participants will receive HIV counseling and the intrapartum/neonatal two-dose NVP prophylaxis regimen to prevent MTCT. Mothers will also be given infant feeding options counseling and information on administering the study drug to the infant. Eligible infants will be randomly assigned to one of two groups. The first group will receive NVP; the second group will receive placebo. Infants will receive the NVP or placebo for the first 6 months of life or until cessation of breastfeeding, whichever occurs earlier.

Follow-up evaluations will be conducted at Weeks 2 and 6 and Months 3, 6, 12, and 18 for mothers, and at Weeks 2, 4, 6, and 8 and Months 3, 4, 5, 6, 9, 12, and 18 for infants. Study visits will include physical examinations, blood tests, and medical histories. Study participants will be followed for up to 3.5 years.

Genders Eligible for Study:  Both

Criteria

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
• Planning on breastfeeding

Exclusion Criteria for Mothers

• Complications with this pregnancy
• Active serious infection other than HIV
• Other serious illnesses

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

Exclusion Criteria for Infants

• Unable to breastfeed (e.g., mother died or is otherwise unable or unwilling to breastfeed)
• Skin rash grade 2B (urticaria), grade 3 or above
• Confirmed or suspected clinical hepatitis
• Serious illness or condition that would interfere with compliance with study procedures