A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

• Status: Suspended
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study will look at whether emtricitabine is as safe and effective as abacavir (ABC) when taken with stavudine (d4T) and efavirenz (EFV) in patients who have never taken anti-HIV drugs.

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

Details

• Lead Sponsor: Triangle Pharmaceuticals
• Treatments: Abacavir; Dideoxynucleosides; Efavirenz; Emtricitabine; Stavudine

Criteria

Inclusion Criteria

You may be eligible if you:

• Are HIV-positive and generally healthy.

• Have a viral load of 5,000 copies/ml or more.

• Have CD4 cell counts of 200 cells/mm3 or more.

• Are age 18 or older.

• Agree to practice sexual abstinence or use effective barrier methods of birth control (such as condoms).

Exclusion Criteria

You will not be eligible if you:

• Have ever taken anti-HIV drugs for 3 days or more.

• Have had certain AIDS-related infections.

• Have had severe diarrhea within the past 30 days.

• Are unable to eat at least 1 meal a day due to nausea, vomiting, or stomach pain.

• Are being treated for active tuberculosis (TB).

• Are pregnant or breast-feeding.

• Use illegal drugs or alcohol that make it difficult for you to take study drugs or keep clinic appointments.

• Are taking certain medications, or have certain other conditions or diseases (see the technical summary for more detail).