Clinical trial NCT00046345: Atazanavir for HIV Infected Individuals: An Early Access Program
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: HIV Infections
Keywords: treatment experienced
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2002-09-30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
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facility: Local Institution
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city: Madison
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city: Madison
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city: Milwaukee
country: United States
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city: Ponce
country: Puerto Rico
facility: Local Institution
city: Rio Piedras
country: Puerto Rico
facility: Local Institution
Study officials:
References: