drugset / Trial / NCT00724711

Safety and Efficacy Study of Switching From Epzicom to Truvada

NCT00724711

Phase 4 Completed 312 enrolled Gilead Sciences
RandomizedParallel-groupOpen-labelTreatment

Summary

This protocol describes a prospective, randomized, open-label, multicenter study to evaluate the safety and efficacy of switching from fixed dose abacavir (ABC)/lamivudine (3TC) to fixed dose emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in virologically suppressed, human immunodeficiency virus type 1 (HIV-1) infected subjects maintained on a ritonavir-boosted protease inhibitor (PI/r)-containing antiretroviral (ARV) regimen. Duration of treatment is 48 weeks.

Timeline

Start
2008-07
Primary completion
2011-03
Completion
2011-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Abacavir Other / unclassified 600 mg Oral
Comparator Lamivudine Other / unclassified 300 mg Oral
Subject Tenofovir disoproxil fumarate Small molecule 300 mg
Subject emtricitabine Other / unclassified 200 mg