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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Phase III Study Comparing the Antiviral Efficacy and Safety of BMS-232632 With Efavirenz; Each in Combination With Fixed Dose Zidovudine-Lamivudine

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Atazanavir
* Drug: Lamivudine/Zidovudine
* Drug: Efavirenz


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atazanavir|nan|
|Drug: Lamivudine/Zidovudine|nan|
|Drug: Efavirenz|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Placebos, Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, Lamivudine, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, BMS 232632, efavirenz