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

This study has been completed.

Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00013897
  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 III

MedlinePlus related topics:   AIDS   

ChemIDplus related topics:   Zidovudine    Lamivudine    Efavirenz    Atazanavir sulfate    BMS 232632   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind
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

Further study details as provided by Bristol-Myers Squibb:

Study Start Date:   February 2001

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  Show 99 Study Locations

Sponsors and Collaborators
Bristol-Myers Squibb
  More Information


BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
 
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   302C, AI424-034
First Received:   March 31, 2001
Last Updated:   October 1, 2007
ClinicalTrials.gov Identifier:   NCT00013897
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

Study placed in the following topic categories:
Virus Diseases
Efavirenz
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lamivudine
Zidovudine
Atazanavir
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 10, 2008




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