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Safety and Efficacy Study of Switching From Epzicom to Truvada

NCT00724711 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2012-05-28

Study results available
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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.

Conditions

  • HIV Infection

Interventions

DRUG

emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)

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

DRUG

abacavir (ABC)/lamivudine (3TC)

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

Sponsors & Collaborators

Principal Investigators

  • Todd Fralich, MD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2011-03-31
Completion
2011-04-30

Countries

  • United States
  • Canada
  • Puerto Rico

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00724711 on ClinicalTrials.gov