Tenofovir in Pregnancy (TIP) Study

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Investigator: John A. Shepherd, PhD
Sponsor: National Foundation for the CDC and Prevention

Location(s): China

Description

The Tenofovir in Pregnancy (TIP) Study in Guangxi, China, and will evaluate the safety of a tenofovir-containing triple prophylactic regimen during pregnancy for HIV and HBV-co-infected pregnant women and their infants, with a view to future evaluation of its efficacy in reducing breakthrough HBV transmission to the infant.

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.