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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00013897
First received: March 31, 2001
Last updated: April 28, 2011
Last verified: April 2011
  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:


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)
Detailed 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.

  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
Sponsors 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 April 16, 2014