- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002240
Study of a New Protease Inhibitor, BMS-232632, in Combination With Other Anti-HIV Drugs
April 28, 2011 updated by: Bristol-Myers Squibb
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Ottawa, Ontario, Canada
- Ottawa General Hospital
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Alabama
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Birmingham, Alabama, United States, 35294
- Univ of Alabama at Birmingham
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Birmingham, Alabama, United States, 35203
- Clinsites / Sorra Research Ctr
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California
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San Diego, California, United States, 92103
- UCSD Treatment Ctr
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San Francisco, California, United States, 94110
- UCSF - San Francisco Gen Hosp
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Colorado
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Denver, Colorado, United States, 80262
- Univ of Colorado / Health Science Ctr
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District of Columbia
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Washington, District of Columbia, United States, 20009
- ViRx / Dupont Circle Physicians Group
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Georgia
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Atlanta, Georgia, United States, 30308
- AIDS Research Consortium of Atlanta
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Illinois
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Chicago, Illinois, United States, 60612
- Rush Presbyterian - Saint Luke's Med Ctr
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Missouri
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St Louis, Missouri, United States, 63108
- Washington Univ School of Medicine
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New York
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Albany, New York, United States, 12208
- Albany Med College
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New York, New York, United States, 10003
- Beth Israel Med Ctr
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New York, New York, United States, 10032
- Columbia Presbyterian Med Ctr
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Ohio
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Cleveland, Ohio, United States, 44106
- Case Western Reserve Univ
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Texas
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Dallas, Texas, United States, 75235
- Univ of Texas Southwestern Med Ctr of Dallas
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Dallas, Texas, United States, 75219
- Oak Lawn Physicians Group
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Galveston, Texas, United States, 77555
- Univ TX Galveston Med Branch
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 1999
Primary Completion (Actual)
December 1, 2001
Study Completion (Actual)
December 1, 2001
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
May 4, 2011
Last Update Submitted That Met QC Criteria
April 28, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Protease Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Stavudine
- Didanosine
- Nelfinavir
- Atazanavir Sulfate
Other Study ID Numbers
- 302A
- AI424-007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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