drugset / Trial / NCT00053638

A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy

NCT00053638

Phase 3 Completed 345 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. Study physicians will evaluate subjects to determine if they have certain medical conditions, laboratory test values, medication use, or drug allergies that would exclude them from the study.

Timeline

Start
2003-02
Primary completion
2004-10
Completion
2004-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Abacavir Other / unclassified
Subject Efavirenz Other / unclassified
Subject Lamivudine Other / unclassified
Subject Tenofovir Small molecule