Study of a New Protease Inhibitor, BMS-232632, in Combination With Other Anti-HIV Drugs
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002240
First received: November 2, 1999
Last updated: April 28, 2011
Last verified: April 2011
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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:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Stavudine
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) |
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 | |
| 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 | |
| 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
Additional Information:
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 Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Didanosine Stavudine Reverse Transcriptase Inhibitors |
Nelfinavir Anti-HIV Agents Atazanavir Protease Inhibitors HIV Protease Inhibitors Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013