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Atazanavir for HIV Infected Individuals: An Early Access Program

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT00046345
Enrollment
Unknown
Registered
2002-09-30
Start date
2002-05-31
Completion date
2003-07-31
Last updated
2011-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

treatment experienced

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.

Interventions

DRUGAtazanavir (BMS-232632)

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion 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.

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026