Atazanavir for HIV Infected Individuals: An Early Access Program

Bristol-Myers Squibb (BMS)

Status

Conditions: HIV Infections

Treatments: Drug: Atazanavir (BMS-232632)

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT00046345

AI424-900

Details and patient eligibility

About

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.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.