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

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Atazanavir Drug: Nelfinavir mesylate Drug: Stavudine Drug: Didanosine	Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS HIV/AIDS Medicines

Drug Information available for: Stavudine Proteinase inhibitor Didanosine Nelfinavir Nelfinavir Mesylate Atazanavir Atazanavir sulfate

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:


Study Start Date:	March 1999
Study Completion Date:	December 2001
Primary Completion Date:	December 2001 (Final data collection date for primary outcome measure)

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002240

Locations


United States, Alabama
Clinsites / Sorra Research Ctr
Birmingham, Alabama, United States, 35203
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
UCSD Treatment Ctr
San Diego, California, United States, 92103
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94110
United States, Colorado
Univ of Colorado / Health Science Ctr
Denver, Colorado, United States, 80262
United States, District of Columbia
ViRx / Dupont Circle Physicians Group
Washington, District of Columbia, United States, 20009
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
United States, Missouri
Washington Univ School of Medicine
St Louis, Missouri, United States, 63108
United States, New York
Albany Med College
Albany, New York, United States, 12208
Beth Israel Med Ctr
New York, New York, United States, 10003
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
United States, Ohio
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
United States, Texas
Oak Lawn Physicians Group
Dallas, Texas, United States, 75219
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States, 75235
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77555
Canada, Ontario
Ottawa General Hospital
Ottawa, Ontario, Canada

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Publications:

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

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, 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)

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)

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)

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)


ClinicalTrials.gov Identifier:	NCT00002240 History of Changes
Other Study ID Numbers:	302A, AI424-007
Study First Received:	November 2, 1999
Last Updated:	April 28, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:


Didanosine Dose-Response Relationship, Drug Drug Therapy, Combination Stavudine	HIV Protease Inhibitors Reverse Transcriptase Inhibitors Anti-HIV Agents Nelfinavir

Additional relevant MeSH terms:


HIV Protease Inhibitors Protease Inhibitors Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents	Antiviral Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015