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Atazanavir for HIV Infected Individuals: An Early Access Program
Expanded access is no longer available for this treatment.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00046345
First received: September 26, 2002
Last updated: April 13, 2011
Last verified: April 2011
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Purpose
The purpose of this clinical research study is to provide atazanavir to patients infected with human immunodeficiency virus (HIV) whose antiviral medications are no longer working to control HIV activity within the body and who are unable to create a new treatment regimen using other available anti-HIV drugs, because of either side effects or treatment failure previously taken. The safety of this treatment will also be studied.
| Condition | Intervention |
|---|---|
| HIV Infections | Drug: Atazanavir (BMS-232632) |
| Study Type: | Expanded Access What is Expanded Access? |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Eligibility| Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key inclusion criteria:
- Patients eligible for inclusion into the EAP are those that are a virologic failure due to resistance, intolerance and/or adherence problems with current anti-HIV medications;
- OR have multiple toxicities or intolerance to their anti-HIV medication but are not a virologic failure;
- OR have severe elevated lipids in the blood (e.g., cholesterol, triglycerides) that do not respond to lipid-lowering medication.
Key exclusion Criteria:
- Restrictions apply regarding the use of atazanavir with specific medications which may have a potential to cause possible side effects when taken together.
- Patients will also be excluded for any of the following reasons: 1) pregnancy or breast feeding, 2) elevated liver enzymes, 3) significant cardiovascular disease, or 4) other restrictions as indicated in the protocol.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00046345
Show 165 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00046345
Show 165 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
More Information
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00046345 History of Changes |
| Other Study ID Numbers: |
AI424-900 |
| Study First Received: | September 26, 2002 |
| Last Updated: | April 13, 2011 |
Keywords provided by Bristol-Myers Squibb:
|
treatment experienced |
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 Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on June 23, 2017