Comparison of Three Anti-HIV Regimens to Prevent Nevirapine Resistance in Women Who Take Nevirapine During Pregnancy
Status:
Completed
Trial end date:
2011-11-01
Target enrollment:
Participant gender:
Summary
HIV infected pregnant women may take single-dose nevirapine (SD NVP) prior to giving birth to
prevent mother-to-child transmission (MTCT) of HIV. However, SD NVP may cause NVP resistance
in the mother, potentially ruling out some treatment options in the future. The purpose of
this study is to determine which of three anti-HIV drug regimens most effectively reduces the
development of maternal NVP resistance in HIV infected pregnant women. The effectiveness of
short-term (7 day therapy) versus long-term (21-day therapy) regimens will also be compared.
The study hypotheses are: 1) intrapartum SD NVP with a 21-day course of antiretroviral
therapy (ART) results in less frequent selection of NVP-resistant HIV-1 variants than
intrapartum SD NVP with a 7-day course of ART, and 2) a 7- or 21-day course of
lamivudine/zidovudine (3TC/ZDV), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), or
lopinavir/ritonavir (LPV/r) following SD NVP will not select nucleoside reverse transcriptase
inhibitor (NRTI)- or protease inhibitor (PI)- resistant HIV-1 variants.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Lamivudine Lamivudine, zidovudine drug combination Lopinavir Nevirapine Ritonavir Tenofovir Zidovudine