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

Launched by TRIANGLE PHARMACEUTICALS · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility 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).