A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy
NCT00053638 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 345
Last updated 2010-10-04
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.
Conditions
- HIV Infection
Interventions
- DRUG
-
efavirenz
- DRUG
-
tenofovir
- DRUG
-
abacavir/lamivudine
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials, MD · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-02-28
- Primary Completion
- 2004-10-31
- Completion
- 2004-10-31
Countries
- United States
Study Locations
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