A Comparison of BMS-232632 With Efavirenz, Each in Combination With Zidovudine-Lamivudine

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Drug: Efavirenz; Drug: Lamivudine/Zidovudine; Drug: Atazanavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00013897

302C

AI424-034

Details and patient eligibility

About

The purpose of this study is to compare the effectiveness of treatment with BMS-232632 to that of efavirenz (EFV) when both are used with zidovudine (ZDV) and lamivudine (3TC).

Full description

This is a multinational, 2-arm study. Patients in 1 arm receive BMS-232632 plus EFV placebo capsules. Patients in the other arm receive EFV plus BMS-232632 placebo. Both arms also receive a fixed dose of ZDV-3TC.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Have a viral load of 2,000 or more copies/ml and a CD4 cell count of 100 or more cells/mm3 (or 75 or more cells/mm3 with no prior history of AIDS-defining diagnosis) within 2 weeks before randomization.
• Are at least 16 years old.
• Have signed consent of parent or guardian if under 18 years of age.
• Are willing to use effective barrier methods of birth control.
• Are available for follow-up for at least 52 weeks.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have had anti-HIV treatment within 30 days before screening.
• Have a recently diagnosed HIV-related infection.
• Have any medical condition requiring treatment at enrollment.
• Have recently become HIV infected.
• Have acute hepatitis within 30 days of study entry. Certain patients with chronic hepatitis will be eligible.
• Expect to need or have taken drugs with myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months before study. Expect to need methadone, ribavirin/interferons, neurotoxic drugs or drugs that affect CYP3A4.
• Abuse alcohol or drugs.
• Have severe diarrhea within 30 days before study entry.
• Are pregnant or breast-feeding.
• Have a history of hemophilia.
• Have a history of bilateral peripheral neuropathy.
• Cannot take medicines by mouth.
• Have any other conditions that the doctor thinks would interfere with the study.