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 II

MedlinePlus related topics:

AIDS AIDS Medicines

Drug Information available for:

Didanosine Stavudine Nelfinavir Nelfinavir Mesylate Atazanavir sulfate BMS 232632

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Safety Study

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

Further study details as provided by Bristol-Myers Squibb:

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

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

Locations


United States, Alabama
	Univ of Alabama at Birmingham
	Birmingham, Alabama, United States, 35294
	Clinsites / Sorra Research Ctr
	Birmingham, Alabama, United States, 35203

United States, California
	UCSF - San Francisco Gen Hosp
	San Francisco, California, United States, 94110
	UCSD Treatment Ctr
	San Diego, California, United States, 92103

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
	Beth Israel Med Ctr
	New York, New York, United States, 10003
	Columbia Presbyterian Med Ctr
	New York, New York, United States, 10032
	Albany Med College
	Albany, New York, United States, 12208

United States, Ohio
	Case Western Reserve Univ
	Cleveland, Ohio, United States, 44106

United States, Texas
	Univ of Texas Southwestern Med Ctr of Dallas
	Dallas, Texas, United States, 75235
	Oak Lawn Physicians Group
	Dallas, Texas, United States, 75219
	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

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)

Study ID Numbers:	302A, AI424-007
First Received:	November 2, 1999
Last Updated:	October 1, 2007
ClinicalTrials.gov Identifier:	NCT00002240
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

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

Stavudine

Didanosine

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Atazanavir

Nelfinavir

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

HIV Protease Inhibitors

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Protease Inhibitors

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00002240