Between July 2006 and May 2008, we enrolled pregnant women with HIV-1 infection in the Mma Bana Study (meaning “mother of the baby” in Setswana) in southern Botswana. Women with CD4+ cell counts of 200 or more were randomly assigned (in permuted blocks stratified according to clinical site) to receive either 300 mg of abacavir, 300 mg of zidovudine, and 150 mg of lamivudine coformulated as Trizivir (GlaxoSmith-Kline) twice daily (the NRTI group) or 400 mg of lopinavir and 100 mg of ritonavir coformulated as Kaletra (Abbott) with 300 mg of zidovudine and 150 mg of lamivudine coformulated as Combivir (GlaxoSmithKline) twice daily (the protease-inhibitor group). Women with CD4+ cell counts of less than 200 cells per cubic millimeter or with an acquired immunodeficiency syndrome (AIDS)–defining illness received standard-of-care treatment for Botswana: 200 mg of nevirapine, 300 mg of zidovudine, and 150 mg of lamivudine twice daily (after a 2-week lead-in period of oncedaily nevirapine at a dose of 200 mg) (the observational group). Women in the randomized groups began to receive HAART between 26 and 34 weeks’ gestation and continued it through weaning or 6 months post partum (whichever occurred first), and women in the observational group began to receive HAART between 18 and 34 weeks’ gestation and continued treatment indefinitely. We report results for the primary end points at 6 months post partum.
Infants received single-dose nevirapine (6 mg) at birth and received zidovudine (4 mg per kilogram of body weight twice daily) from birth through 4 weeks. Women were counseled to exclusively breast-feed and to complete weaning 3 days before the 6-month study visit. Infants were provided free formula and foods from the time of weaning (whenever it occurred) through 12 months.
Study drugs were provided by GlaxoSmith-Kline (Trizivir and Combivir) and Abbott Pharmaceuticals (Kaletra), but these companies had no other role in the design of the study, the accrual or analysis of the data, the preparation of the manuscript, or the decision to submit the manuscript for publication. The Botswana government provided nevirapine, Combivir, additional medications, and some laboratory testing. The Health Research Development Committee of Botswana and the Human Subjects Committee of the Harvard School of Public Health approved the study protocol and amendments. An independent data and safety monitoring board reviewed safety and efficacy data approximately every 6 months. The full study protocol including the statistical-analysis plan, is available with the full text of this article atNEJM.org . All authors vouch for the completeness and veracity of the reported data and analyses and attest that the study as reported conforms with the protocol.
Infants received single-dose nevirapine (6 mg) at birth and received zidovudine (4 mg per kilogram of body weight twice daily) from birth through 4 weeks. Women were counseled to exclusively breast-feed and to complete weaning 3 days before the 6-month study visit. Infants were provided free formula and foods from the time of weaning (whenever it occurred) through 12 months.
Study drugs were provided by GlaxoSmith-Kline (Trizivir and Combivir) and Abbott Pharmaceuticals (Kaletra), but these companies had no other role in the design of the study, the accrual or analysis of the data, the preparation of the manuscript, or the decision to submit the manuscript for publication. The Botswana government provided nevirapine, Combivir, additional medications, and some laboratory testing. The Health Research Development Committee of Botswana and the Human Subjects Committee of the Harvard School of Public Health approved the study protocol and amendments. An independent data and safety monitoring board reviewed safety and efficacy data approximately every 6 months. The full study protocol including the statistical-analysis plan, is available with the full text of this article at