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

March 31, 2001
April 28, 2011
February 2001
April 2003   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00013897 on ClinicalTrials.gov Archive Site
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A Comparison of BMS-232632 With Efavirenz, Each in Combination With Zidovudine-Lamivudine
A Phase III Study Comparing the Antiviral Efficacy and Safety of BMS-232632 With Efavirenz; Each in Combination With Fixed Dose Zidovudine-Lamivudine

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).

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.

Interventional
Phase 3
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
  • Drug: Atazanavir
  • Drug: Lamivudine/Zidovudine
  • Drug: Efavirenz
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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April 2003
April 2003   (final data collection date for primary outcome measure)

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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   United States,   South Africa,   Italy,   Thailand,   France,   Belgium,   Puerto Rico,   Panama,   Russian Federation,   Chile,   Canada,   Spain,   Portugal,   Venezuela,   Peru,   Guatemala,   Malaysia,   Israel,   United Kingdom,   Germany,   Hungary,   Costa Rica,   Switzerland
 
NCT00013897
302C, AI424-034
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Bristol-Myers Squibb
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Bristol-Myers Squibb
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP