drugset / Trial / NCT00135382

Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen

NCT00135382

Phase 3 Completed 254 enrolled Bristol-Myers Squibb
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a protease inhibitor (PI)-based regimen to an efavirenz-based regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels \< 50 copies/mL. In addition, a simplified once-daily regimen will improve adherence and quality of life.

Timeline

Start
2002-06
Primary completion
2005-10
Completion
2005-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Efavirenz Other / unclassified
Background Lamivudine Other / unclassified
Background Videx EC Unknown