The purpose of this study is to compare a regimen of tenofovir/lamivudine/lopinavir-ritonavir to the WHO-recommended and locally practiced standard of care regimen consisting of zidovudine/lamivudine/lopinavir-ritonavir during the second and third trimesters of pregnancy in HIV and HBV co-infected women. This is a phase II study evaluating the safety of the test regimen in pregnant women and their newborns. While the study is not powered to examine efficacy, preliminary estimates of transmission of HIV and HBV to the infants and of the rate of resistance development will be obtained.
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Tenofovir Safety for mothers measured by incidence of serious adverse events (SAEs)
Timeframe: From baseline (14-28 weeks gestation) through 12 months postpartum
Dual Energy X-ray absorptiometry (DXA) scans of bone mineral density
Timeframe: from delivery through 6 months postpartum
Maternal Tenofovir Pharmacokinetics
Timeframe: 16 weeks gestation through delivery
Infant Tenofovir Pharmacokinetics
Timeframe: one timepoint within 12 hours of delivery
Tenofovir safety for infants measured by incidence of serious adverse events (SAEs)
Timeframe: from birth through 12 months of age