Study of a New Protease Inhibitor, BMS-232632, in Combination With Other Anti-HIV Drugs
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ClinicalTrials.gov Identifier: NCT00002240 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: May 4, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Atazanavir Drug: Nelfinavir mesylate Drug: Stavudine Drug: Didanosine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
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 |
Study Start Date : | March 1999 |
Actual Primary Completion Date : | December 2001 |
Actual Study Completion Date : | December 2001 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002240
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 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
Publications:
ClinicalTrials.gov Identifier: | NCT00002240 History of Changes |
Other Study ID Numbers: |
302A AI424-007 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | May 4, 2011 |
Last Verified: | April 2011 |
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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Atazanavir Sulfate HIV Protease Inhibitors Nelfinavir |
Stavudine Didanosine Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Antimetabolites Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |