Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment
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ClinicalTrials.gov Identifier: NCT00004584 |
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: Ritonavir Drug: Saquinavir | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Primary Purpose: | Treatment |
Official Title: | Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, BMS-232632, in Combination Regimen(s) as Compared to a Reference Combination Regimen(s) in Antiretroviral-Experienced HIV-Infected Subjects |
Study Start Date : | December 1999 |
Actual Primary Completion Date : | January 2002 |
Actual Study Completion Date : | January 2002 |


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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 a viral load (level of HIV in the blood) of at least 2,000 copies/ml.
- Have a CD4 count of at least 100 cells/mm3 (or at least 75 cells/mm3 in patients who have never had an AIDS-defining illness).
- Are currently receiving an anti-HIV drug combination that includes a protease inhibitor or nonnucleoside reverse transcriptase inhibitor (NNRTI), and they have been taking this drug combination for at least 24 weeks. They must have responded well to this treatment at first (their viral load decreased) but are currently experiencing an increase in viral load.
- Will most likely respond well to the study drugs, as shown by the results of a lab test.
- Are at least 18 years old.
- Agree to use effective barrier methods of birth control (such as condoms).
- Are available for follow-up for at least 48 weeks.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have a newly diagnosed opportunistic (HIV-related) infection requiring treatment.
- Have only recently become HIV positive.
- Abuse alcohol or drugs.
- Have severe diarrhea within 30 days of study entry.
- Have hemophilia.
- Have a history of pancreatitis.
- Have hepatitis within 30 days of study entry.
- Have peripheral neuropathy (a painful condition affecting the nervous system).
- Are unable to take medications by mouth.
- Are pregnant or breast-feeding.

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): NCT00004584

Additional Information:
Publications:
ClinicalTrials.gov Identifier: | NCT00004584 History of Changes |
Other Study ID Numbers: |
302B AI424-009 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | May 4, 2011 |
Last Verified: | April 2011 |
Keywords provided by Bristol-Myers Squibb:
Dose-Response Relationship, Drug Drug Therapy, Combination HIV Protease Inhibitors Ritonavir |
Saquinavir Reverse Transcriptase Inhibitors Anti-HIV Agents |
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 Ritonavir Atazanavir Sulfate |
HIV Protease Inhibitors Saquinavir Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |