drugset / Trial / NCT00144183

A Study of Single Dose Nevirapine (NVP) Combined With Combivir® for the Prevention of Mother to Child Transmission (pMTCT) - Treatment Options Preservation Study (TOPS)

NCT00144183

Phase 3 Completed 407 enrolled Boehringer Ingelheim
RandomizedParallel-groupOpen-labelPrevention

Summary

To determine whether a regimen of single dose nevirapine combined with either 4 or 7 days of Combivir®, compared to a regimen of single dose nevirapine, for the prevention of mother to child transmission can reduce the rate of development of drug resistant mutations of HIV-1, in HIV-1 infected pregnant women, who have not received antiretroviral therapy previously.

Timeline

Start
2003-01
Primary completion
2007-01
Completion
2007-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Lamivudine Other / unclassified
Subject Nevirapine Small molecule 200 mg
Subject Zidovudine Small molecule

Indications