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

• Status: Completed
• Trial end date: 2003-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Atazanavir Sulfate; Efavirenz; Lamivudine; Lamivudine, zidovudine drug combination; Zidovudine

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.