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

NCT ID: NCT00002240

Last Updated: 2011-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-03-31
• Study Completion Date: 2001-12-31

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.

Conditions

HIV Infections

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Atazanavir

Intervention Type: DRUG

Nelfinavir mesylate

Intervention Type: DRUG

Stavudine

Intervention Type: DRUG

Didanosine

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Clinsites / Sorra Research Ctr

Birmingham, Alabama, United States

Univ of Alabama at Birmingham

Birmingham, Alabama, United States

UCSD Treatment Ctr

San Diego, California, United States

UCSF - San Francisco Gen Hosp

San Francisco, California, United States

Univ of Colorado / Health Science Ctr

Denver, Colorado, United States

ViRx / Dupont Circle Physicians Group

Washington D.C., District of Columbia, United States

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States

Washington Univ School of Medicine

St Louis, Missouri, United States

Albany Med College

Albany, New York, United States

Beth Israel Med Ctr

New York, New York, United States

Columbia Presbyterian Med Ctr

New York, New York, United States

Case Western Reserve Univ

Cleveland, Ohio, United States

Oak Lawn Physicians Group

Dallas, Texas, United States

Univ of Texas Southwestern Med Ctr of Dallas

Dallas, Texas, United States

Univ TX Galveston Med Branch

Galveston, Texas, United States

Ottawa General Hospital

Ottawa, Ontario, Canada

Countries

United States; Canada

References

Piliero P, et al. AI424-007: Atazanavir: an HIV protease inhibitor (PI) that does not cause lipid elevations. International Symposium on Drugs Affecting Lipid Metabolism. 2001 Sept 9 - 12

Reference Type: BACKGROUND

Gatell JM, et al. AI424-007: Atazanavir (BMS-232632): Absence of serum lipid changes after 48 weeks of treatment in treatment-naive HIV-positive subjects (Trial AI424007). 8th European Conf on Clinical Aspects and Treatment of HIV Infection (8th ECCATHI). 2001 Oct 28 - 31 (abstract no 223)

Reference Type: BACKGROUND

Piliero P, et al. AI424-007: BMS-232632 - Clinical Trial AI424007: Safety, Efficacy of a Once-Daily Protease Inhibitor at 24 Weeks. 5th International Congress on Drug Therapy in HIV Infection. 2000 Octr 22 - 26

Reference Type: BACKGROUND

Sanne I, Piliero P, Wood R, Kelleher T, Cross A, Mongillo A, Schnittman S. AI424-007: Safety and Antiviral Efficacy of a Novel Once-Daily HIV-1 Protease Inhibitor BMS-232632: Preliminary Results from a Phase II Clinical Trial. 7th Conf Retroviruses and Opportunistic Infect. 2000 Jan 30-Feb 2 (abstract no 672)

Reference Type: BACKGROUND

Squires K, Gatell J, Piliero P, Sanne I, Wood R, Schnittman SM. AI424-007: 48-week safety and efficacy results from a phase II study of a once-daily HIV-1 protease inhibitor (PI), BMS-232632. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 15)

Reference Type: BACKGROUND

Sanne I, Piliero P, Wood R, Kelleher T, Cross A, Mongillo A, Schnittman S. AI424-007: Safety and Antiviral Efficacy of a Once-Daily HIV-1 Protease Inhibitor BMS-232632: 24 Week Results from a Phase II Clinical Trial. 40th Interscience Conf on Antimicrobial Agents and Chemotherapy. 2000 September 17-20 (abstract no 691)

Reference Type: BACKGROUND

Piliero P, Cahn P, Pantaleo G, Gatell JM, Squires K, Percival L, Sanne I, Wood R, Phanuphak P, Shelton S, Lazzarin A, Thiry A, Kelleher T, Giordano M, Schnittman SM. AI424-007: Atazanavir: A Once-Daily Protease Inhibitor with a Superior Lipid Profile-Results of Clinical Trials Beyond Week 48. 9th Conf on Retroviruses and Opportunistic Infect. 2002 Feb 24 - 28 (abstract no 706-T)

Reference Type: BACKGROUND

Other Identifiers

AI424-007

Identifier Type: -

Identifier Source: secondary_id

302A

Identifier Type: -

Identifier Source: org_study_id