Study of a New Protease Inhibitor, BMS-232632, in Combination With Other Anti-HIV Drugs - Tabular View

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

October 1, 2007

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00002240 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Study of a New Protease Inhibitor, BMS-232632, in Combination With Other Anti-HIV Drugs

Official Title ^ICMJE

Evaluation of the Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, BMS-232632, Alone and in Combination With d4T and ddI as Compared to a Reference Combination Regimen

Brief Summary

The purpose of this study is to evaluate a new protease inhibitor known as BMS-232632. This drug will be given in combination with 2 other anti-HIV drugs (stavudine and didanosine). The effectiveness of BMS-232632 against HIV infection will be compared to that of nelfinavir, a protease inhibitor that is already commonly prescribed.

Detailed Description

Patients are randomized to receive one of two drug regimens: BMS-232632, ddI, and d4T or NFV, ddI, and d4T. Three different doses of BMS-232632 are used in this study. Randomization is stratified for HIV RNA level (less than 30,000 copies/ml versus 30,000 or greater copies/ml). Patients remain on their drug regimen for 48 weeks.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Safety Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Atazanavir
Drug: Nelfinavir mesylate
Drug: Stavudine
Drug: Didanosine

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 ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria

Patients may be eligible for this study if they:

Are HIV-positive.
Have an HIV blood level between 2,000 and 200,000 copies/ml.
Have a CD4 cell count of at least 100 cells/mm3.
Are 18 years of age or older.
Are available for follow-up for at least 48 weeks.
Agree to use a barrier method of birth control (such as condoms) during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

Have ever received anti-HIV (antiretroviral) treatment.
Have an HIV-related opportunistic infection or condition at the time of study entry.
Have primary HIV infection, meaning they have recently been infected.
Have had severe diarrhea within the 30 days before study entry.
Have hemophilia.
Have a history of pancreatitis, hepatitis, or a peripheral neuropathy.
Are unable to tolerate oral medication.
Are pregnant or breast-feeding.
Abuse alcohol or drugs.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00002240

Responsible Party

Study ID Numbers ^ICMJE

302A, AI424-007

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

October 2007

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