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

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.

Timeline

Start

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Primary completion

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Completion

2005-05

Publications

• Results Lee EJ, Kantor R, Zijenah L, Sheldon W, Emel L, Mateta P, Johnston E, Wells J, Shetty AK, Coovadia H, Maldonado Y, Jones SA, Mofenson LM, Contag CH, Bassett M, Katzenstein DA; HIVNET 023 Study Team. Breast-milk shedding of drug-resistant HIV-1 subtype C in women exposed to single-dose nevirapine. J Infect Dis. 2005 Oct 1;192(7):1260-4. doi: 10.1086/444424. Epub 2005 Aug 23.
• Results Shetty AK, Coovadia HM, Mirochnick MM, Maldonado Y, Mofenson LM, Eshleman SH, Fleming T, Emel L, George K, Katzenstein DA, Wells J, Maponga CC, Mwatha A, Jones SA, Abdool Karim SS, Bassett MT; HIVNET 023 Study Team. Safety and trough concentrations of nevirapine prophylaxis given daily, twice weekly, or weekly in breast-feeding infants from birth to 6 months. J Acquir Immune Defic Syndr. 2003 Dec 15;34(5):482-90. doi: 10.1097/00126334-200312150-00006.

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Indications