Atazanavir for HIV Infected Individuals: An Early Access Program

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00046345
First received: September 26, 2002
Last updated: April 13, 2011
Last verified: April 2011

September 26, 2002
April 13, 2011
May 2002
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Complete list of historical versions of study NCT00046345 on ClinicalTrials.gov Archive Site
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Atazanavir for HIV Infected Individuals: An Early Access Program
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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.

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Expanded Access
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HIV Infections
Drug: Atazanavir (BMS-232632)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
No longer available
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July 2003
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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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00046345
AI424-900
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Bristol-Myers Squibb
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Bristol-Myers Squibb
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP