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

Triangle Pharmaceuticals

Status and phase: Suspended; Phase 3

Conditions: HIV Infections

Treatments: Drug: Abacavir sulfate; Drug: Stavudine; Drug: Emtricitabine; Drug: Efavirenz

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002362

298B

FTC-301

Details and patient eligibility

About

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.

Full description

Patients are randomized to receive open-label emtricitabine or ABC in combination with stavudine and efavirenz. Viral load and CD4+ cell counts are compared at Weeks 24 and 48. Patients are followed for 48 weeks.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).