Atazanavir for HIV Infected Individuals: An Early Access Program

• Status: No longer available
• Trial end date: 2003-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Atazanavir Sulfate

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.