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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Breast-feeding is of such critical importance to the general health of the infant, as well as the mother-infant relationship, that special efforts should be made to retain this practice even during the HIV pandemic. Breast-feeding is associated with lower rates of infant gastrointestinal infections and protects against high infant mortality from respiratory and gastrointestinal diseases. These protective effects are greatest in the first 6 months of life. However, HIV is transmitted through breast-feeding. HIV-infected women whose circumstances permit them a choice between breast- and formu...

Gender

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Eligibility 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).