A Comparison of BMS-232632 With Efavirenz, Each in Combination With Zidovudine-Lamivudine
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00013897
First received: March 31, 2001
Last updated: April 28, 2011
Last verified: April 2011
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Atazanavir Drug: Lamivudine/Zidovudine Drug: Efavirenz |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Masking: Double-Blind 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
| Study Start Date: | February 2001 |
| Study Completion Date: | April 2003 |
| Primary Completion Date: | April 2003 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00013897
Show 99 Study Locations
Show 99 Study LocationsSponsors and Collaborators
Bristol-Myers Squibb
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00013897 History of Changes |
| Other Study ID Numbers: | 302C, AI424-034 |
| Study First Received: | March 31, 2001 |
| Last Updated: | April 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bristol-Myers Squibb:
|
Placebos Drug Therapy, Combination Zidovudine HIV Protease Inhibitors Lamivudine RNA, Viral |
Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load BMS 232632 efavirenz |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Zidovudine Lamivudine Reverse Transcriptase Inhibitors Efavirenz |
Lamivudine, zidovudine drug combination Atazanavir HIV Protease Inhibitors Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents Protease Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013