Safety Study of a Tenofovir-containing Drug Regimen for the Prevention of Mother-to-child Transmission of HIV and HBV
Status:
Completed
Trial end date:
2018-08-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborator:
National Center for AIDS/STD Control and Prevention, China CDC