Safety Study of a Tenofovir-containing Drug Regimen for the Prevention of Mother-to-child Transmission of HIV and HBV

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.

Timeline

Start

2012-05

Primary completion

2018-05

Completion

2018-08

Publications

• Wang L, Wiener J, Bulterys M, Wei X, Chen L, Liu W, Liang S, Shepard C, Wang L, Wang A, Zhang F, Kourtis AP. Hepatitis B Virus (HBV) Load Response to 2 Antiviral Regimens, Tenofovir/Lamivudine and Lamivudine, in HIV/ HBV-Coinfected Pregnant Women in Guangxi, China: The Tenofovir in Pregnancy (TiP) Study. J Infect Dis. 2016 Dec 1;214(11):1695-1699. doi: 10.1093/infdis/jiw439. Epub 2016 Sep 22.

Drugs

Indications