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.
ConditionsHIV Infection
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.
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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