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Clinical Trials/NCT00053638
NCT00053638
Completed
Phase 3

A Phase III, Randomized, Open-label, Multicenter Study of the Safety and Efficacy of Efavirenz Versus Tenofovir When Administered in Combination With the Abacavir/Lamivudine Fixed-dose Combination Tablet as a Once-daily Regimen in Antiretroviral-naive HIV-1 Infected Subjects.

GlaxoSmithKline1 site in 1 country345 target enrollmentFebruary 2003

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
HIV Infection
Sponsor
GlaxoSmithKline
Enrollment
345
Locations
1
Primary Endpoint
Viral load response at 48 weeks
Status
Completed
Last Updated
15 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 2003
End Date
October 2004
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Viral load response at 48 weeks

Time Frame: 48 weeks

Secondary Outcomes

  • Safety and tolerability Viral load response at 24 weeks Change in T-cell count Resistance Pharmacokinetics(48 weeks)

Study Sites (1)

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