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

History of Changes

Tracking Information
First Received Date ^ICMJE	September 26, 2002
Last Updated Date	April 13, 2011
Start Date ^ICMJE	May 2002
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00046345 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Atazanavir for HIV Infected Individuals: An Early Access Program
Official Title ^ICMJE	Not Provided
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Expanded Access
Study Phase	Not Provided
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Atazanavir (BMS-232632)
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	No longer available
Enrollment ^ICMJE	Not Provided
Completion Date	July 2003
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	16 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Puerto Rico

Administrative Information
NCT Number ^ICMJE	NCT00046345
Other Study ID Numbers ^ICMJE	AI424-900
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Bristol-Myers Squibb
Verification Date	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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