Atazanavir for HIV Infected Individuals: An Early Access Program

Expanded access is no longer available for this treatment.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00046345

First received: September 26, 2002

Last updated: April 13, 2011

Last verified: April 2011

History of Changes

Purpose

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.

Condition	Intervention
HIV Infections	Drug: Atazanavir (BMS-232632)


Study Type:	Expanded Access What is Expanded Access?

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Atazanavir Atazanavir sulfate

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:


Study Start Date:	May 2002
Estimated Study Completion Date:	July 2003

Eligibility


Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046345

Show 165 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site


ClinicalTrials.gov Identifier:	NCT00046345 History of Changes
Other Study ID Numbers:	AI424-900
Study First Received:	September 26, 2002
Last Updated:	April 13, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:


treatment experienced

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases	Atazanavir Sulfate HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on September 29, 2016

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