A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Abacavir; Efavirenz; Lamivudine; Tenofovir

Criteria

Inclusion criteria:

• Participants must be able to provide informed consent.

• Have documented HIV-1 infection.

• Have not received more than 14 days of prior treatment with antiretroviral drugs.

• Meet laboratory test criteria.

• Women of childbearing potential must abstain from sexual intercourse or use acceptable contraception.

• Must be able to take study medications as directed and complete all study visits and evaluations during the 48 week study.

Exclusion criteria:

• Enrolled in other HIV treatment studies.

• Pregnant or breastfeeding.