Los Angeles, California 90033

  • HIV Infections

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).


Study summary:

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.


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.


Study is Available At:


Original ID:

302C


NCT ID:

NCT00013897


Secondary ID:

AI424-034


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

16 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Bristol-Myers Squibb


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Masking: Double-Blind, Primary Purpose: Treatmen


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Start Date:February 2001
Completion Date:April 2003
Completion Type:Actual
Primary Completion Date:April 2003
Primary Completion Type:Actual
Verification Date:April 2011
Last Changed Date:April 28, 2011
First Received Date:March 31, 2001

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Atazanavir
Intervention Type:Drug
Name:Lamivudine/Zidovudine
Intervention Type:Drug
Name:Efavirenz

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Bristol-Myers Squibb

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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