The Safety of Nevirapine When Given to Breast-Feeding Babies From Birth to Age 6 Months

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if it is safe to give nevirapine (NVP) to breast-feeding babies from birth to the age of 6 months and to determine what dose of NVP should be given.

Breast-feeding has been shown to be very important for the physical and mental health of infants. This is especially true during the first 6 months of life. However, an HIV-positive mother can pass the virus on to her baby by breast-feeding. Because of this risk, HIV-positive mothers are encouraged to formula-feed, not breast-feed, their babies. In developing countries, however, some women cannot afford to formula-feed. If they do formula-feed, these women risk exposing their HIV status. These women have great need for methods that can lower the chance that they will pass HIV on to their babies. This study will test NVP as a way of doing this.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Nevirapine

Criteria

Inclusion Criteria

Mothers may be eligible for this study if they:

• Receive prenatal care at King Edward VIII Hospital, Durban, or St. Mary's Hospital, Marianhill, South Africa; or polyclinics in Chitungwiza District, Zimbabwe.

• Are pregnant for at least 30 weeks before giving birth.

• Are at least 18 years of age.

• Are HIV-positive by 2 ELISA tests.

• Have no serious current or previous problems in pregnancy (e.g., seizures).

• Have a fixed home and/or work address.

• Plan to deliver the baby at a hospital or clinic where the study is based.

• Plan to breast-feed their babies.

• Infants may be eligible for this study if they:

• Are born to women participating in this study.

• Weigh at least 2.5 kg at birth.

• Begin breast-feeding by 48 hours.

Exclusion Criteria

Mothers will not be eligible for this study if they:

• Have AIDS or any other serious illness.

• Are using illegal drugs or have been using alcohol for a long time.

• Are sensitive to NVP.

• Have taken any nonnucleoside reverse transcriptase inhibitors in the past.

• Are using rifampin, rifabutin, ketoconazole, macrolides, or cimetidine.

• Infants will not be eligible for this study if they:

• Have jaundice (yellowing of the skin and whites of eyes) that requires a blood transfusion.

• Have any serious or life-threatening condition(s).