Atazanavir for HIV Infected Individuals: An Early Access Program - Tabular View

Tracking Information
First Received Date ^ICMJE	September 26, 2002
Last Updated Date	June 27, 2008
Start Date ^ICMJE	May 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE (submitted: October 11, 2005)	Primary safety outcome: Frequency and severity of adverse events
Change History	Complete list of historical versions of study NCT00046345 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE (submitted: October 11, 2005)	Secondary safety outcome: Change from baseline in total, LDL and HDL cholesterol, triglycerides and glucose ; frequency of premature study therapy discontinuation. Secondary efficacy outcome: change in HIV RNA and CD4 cell counts

Descriptive Information
Brief Title ^ICMJE	Atazanavir for HIV Infected Individuals: An Early Access Program
Official Title ^ICMJE
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
Study Phase
Study Type ^ICMJE	Expanded Access
Study Design ^ICMJE
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Atazanavir (BMS-232632)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	No longer available
Enrollment ^ICMJE
Completion Date	July 2003
Primary Completion Date
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 ID ^ICMJE	NCT00046345
Responsible Party
Study ID Numbers ^ICMJE	AI424-900
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Bristol-Myers Squibb
Verification Date	October 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP