drugset / Trial / NCT00199979

Zidovudine / Lamivudine + Nevirapine Twice Daily, Versus Tenofovir + Lamivudine + Nevirapine Once Daily in ARV-Naive Patients

NCT00199979

Phase 3 Unknown 250 enrolled MEDEX
RandomizedParallel-groupOpen-labelTreatment

Summary

The study will compare the immuno-virological efficacy, and safety, of a once daily antiretroviral combination (tenofovir + lamivudine + nevirapine) versus a twice daily association (fixed dose combination of zidovudine/lamivudine + nevirapine) in ARV-Naive HIV-1 infected subjects, with CD4 cell count below 350/µL or below 15%, whatever the viral load. Pharmacological (nevirapine concentrations) and virologic data (resistance mutations in case of failure) will also be provided, as well as adherence rate and quality of life in respect of the treatment arms.

Timeline

Start
2005-04
Primary completion
Completion
2008-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Nevirapine Small molecule

Indications