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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002240
• Other study ID #: 302A
• Secondary ID: AI424-007
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: April 28, 2011
• Start date: March 1999
• Est. completion date: December 2001

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2001
• Est. primary completion date: December 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Atazanavir

• Nelfinavir mesylate

• Stavudine

• Didanosine

Locations

Country	Name	City	State
Canada	Ottawa General Hospital	Ottawa	Ontario
United States	Albany Med College	Albany	New York
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Clinsites / Sorra Research Ctr	Birmingham	Alabama
United States	Univ of Alabama at Birmingham	Birmingham	Alabama
United States	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois
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 of Colorado / Health Science Ctr	Denver	Colorado
United States	Univ TX Galveston Med Branch	Galveston	Texas
United States	Beth Israel Med Ctr	New York	New York
United States	Columbia Presbyterian Med Ctr	New York	New York
United States	UCSD Treatment Ctr	San Diego	California
United States	UCSF - San Francisco Gen Hosp	San Francisco	California
United States	Washington Univ School of Medicine	St Louis	Missouri
United States	ViRx / Dupont Circle Physicians Group	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (7)

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)

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)

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

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

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)

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)

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)

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm