CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 312 enrolled
Drug / intervention
emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) +1 moredrug
Likely dose
emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00724711
NCT00724711Phase 4Completed
CompareCT.gov

A Prospective, Randomized, Open Label Phase IV Study to Evaluate the Rationale of Switching From Fixed Dose Abacavir (ABC)/Lamivudine (3TC) to Fixed Dose Tenofovir DF (TDF)/Emtricitabine (FTC) in Virologically Suppressed, HIV-1 Infected Patients Maintained on a Ritonavir Boosted Protease Inhibitor Containing Antiretroviral Regimen

Gilead Sciences·interventional·Posted Jul 29, 2008·Updated May 28, 2012

In Brief

A Phase 4 clinical trial evaluating emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) and abacavir (ABC)/lamivudine (3TC) for HIV Infection. Completed, enrolled 312 participants across 80 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infection
CountriesCanada, Puerto Rico, United States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 29, 2008
Enrollment StartJul 1, 2008
Primary CompletionMar 1, 2011
Study CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.9 years ago

Interventions

emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)drug

FTC 200 mg/TDF 300 mg tablet, once a day

abacavir (ABC)/lamivudine (3TC)drug

ABC 600 mg/3TC 300 mg tablet, once a day