A Comparison of BMS-232632 With Efavirenz, Each in Combination With Zidovudine-Lamivudine
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ClinicalTrials.gov Identifier: NCT00013897 |
Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : May 4, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Atazanavir Drug: Lamivudine/Zidovudine Drug: Efavirenz | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Phase III Study Comparing the Antiviral Efficacy and Safety of BMS-232632 With Efavirenz; Each in Combination With Fixed Dose Zidovudine-Lamivudine |
Study Start Date : | February 2001 |
Actual Primary Completion Date : | April 2003 |
Actual Study Completion Date : | April 2003 |

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00013897

ClinicalTrials.gov Identifier: | NCT00013897 |
Other Study ID Numbers: |
302C AI424-034 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | May 4, 2011 |
Last Verified: | April 2011 |
Placebos Drug Therapy, Combination Zidovudine HIV Protease Inhibitors Lamivudine RNA, Viral |
Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load BMS 232632 efavirenz |
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lamivudine Zidovudine Efavirenz Lamivudine, zidovudine drug combination Atazanavir Sulfate Reverse Transcriptase Inhibitors |
Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Antimetabolites Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers HIV Protease Inhibitors |