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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	March 31, 2001
Last Updated Date	October 1, 2007
Start Date ^†	February 2001
Current Primary Outcome Measures ^†
Original Primary Outcome Measures ^†
Change History	Complete list of historical versions of study NCT00013897 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^†
Original Secondary Outcome Measures ^†

Descriptive Information
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
Brief Summary	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).
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.
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment, Double-Blind
Condition ^†	HIV Infections
Intervention ^†	Drug: Atazanavir Drug: Lamivudine/Zidovudine Drug: Efavirenz
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Completed
Enrollment ^†
Completion Date
Primary Completion Date
Eligibility 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.
Gender	Both
Ages	16 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States, Austria, Belgium, Canada, Chile, Costa Rica, France, Germany, Guatemala, Hungary, Israel, Italy, Malaysia, Panama, Peru, Portugal, Puerto Rico, Russian Federation, South Africa, Spain, Switzerland, Thailand, United Kingdom, Venezuela
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00013897
Responsible Party
Secondary IDs ^††	AI424-034
Study Sponsor ^†	Bristol-Myers Squibb
Collaborators ^††
Investigators ^†
Information Provided By	Bristol-Myers Squibb
Verification Date	October 2007
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.