Atazanavir for HIV Infected Individuals: An Early Access Program

April 13, 2011 updated by: Bristol-Myers Squibb
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
No longer available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Ponce, Puerto Rico
        • Local Institution
      • Rio Piedras, Puerto Rico
        • Local Institution
  • United States
    • Alabama
      • Hobson City, Alabama, United States, 36201
        • Local Institution
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Local Institution
    • Arizona
      • Phoenix, Arizona, United States
        • Local Institution
      • Scottsdale, Arizona, United States
        • Local Institution
      • Tucson, Arizona, United States
        • Local Institution
    • Arkansas
      • Little Rock, Arkansas, United States
        • Local Institution
    • California
      • Bakersfield, California, United States
        • Local Institution
      • Berkeley, California, United States
        • Local Institution
      • Beverly Hills, California, United States
        • Local Institution
      • El Cajon, California, United States
        • Local Institution
      • Fairfield, California, United States
        • Local Institution
      • Fontana, California, United States
        • Local Institution
      • Fountain Valley, California, United States, 92708
        • Local Institution
      • Glendale, California, United States
        • Local Institution
      • Harbor City, California, United States
        • Local Institution
      • Lancaster, California, United States
        • Local Institution
      • Long Beach, California, United States
        • Local Institution
      • Los Angeles, California, United States, 90022
        • Local Institution
      • Mill Valley, California, United States
        • Local Institution
      • Newport Beach, California, United States
        • Local Institution
      • Oakland, California, United States
        • Local Institution
      • Palm Springs, California, United States
        • Local Institution
      • Palo Alto, California, United States
        • Local Institution
      • Panorama City, California, United States
        • Local Institution
      • Paramount, California, United States
        • Local Institution
      • Sacramento, California, United States
        • Local Institution
      • San Bernardino, California, United States
        • Local Institution
      • San Diego, California, United States
        • Local Institution
      • San Francisco, California, United States
        • Local Institution
      • San Jose, California, United States
        • Local Institution
      • San Mateo, California, United States
        • Local Institution
      • San Rafael, California, United States
        • Local Institution
      • Santa Ana, California, United States
        • Local Institution
      • Santa Rosa, California, United States
        • Local Institution
      • Sherman Oaks, California, United States
        • Local Institution
      • Sunnyvale, California, United States
        • Local Institution
      • Tarzana, California, United States
        • Local Institution
      • West Hills, California, United States
        • Local Institution
      • Woodland Hills, California, United States
        • Local Institution
    • Colorado
      • Denver, Colorado, United States, 80204
        • Local Institution
      • Wheat Ridge, Colorado, United States
        • Local Institution
    • Connecticut
      • Hartford, Connecticut, United States
        • Local Institution
      • Meriden, Connecticut, United States
        • Local Institution
      • Norwalk, Connecticut, United States
        • Local Institution
      • Rockville, Connecticut, United States
        • Local Institution
    • District of Columbia
      • Washington, District of Columbia, United States
        • Local Institution
    • Florida
      • Altamonte Springs, Florida, United States
        • Local Institution
      • Bay Pines, Florida, United States
        • Local Institution
      • Bradenton, Florida, United States
        • Local Institution
      • Daytona Beach, Florida, United States
        • Local Institution
      • Fort Lauderdale, Florida, United States
        • Local Institution
      • Fort Myers, Florida, United States
        • Local Institution
      • Gainesville, Florida, United States, 32608
        • Local Institution
      • Hollywood, Florida, United States
        • Local Institution
      • Jacksonville, Florida, United States
        • Local Institution
      • Key West, Florida, United States
        • Local Institution
      • Miami, Florida, United States
        • Local Institution
      • Miami Beach, Florida, United States
        • Local Institution
      • North Miami Beach, Florida, United States
        • Local Institution
      • North Palm Beach, Florida, United States
        • Local Institution
      • Oakland Park, Florida, United States
        • Local Institution
      • Pensacola, Florida, United States
        • Local Institution
      • Plantation, Florida, United States
        • Local Institution
      • Pompano Beach, Florida, United States
        • Local Institution
      • Sarasota, Florida, United States
        • Local Instituton
      • Tampa, Florida, United States
        • Local Institution
      • Vero Beach, Florida, United States
        • Local Institution
      • Winter Haven, Florida, United States
        • Local Institution
      • Winter Park, Florida, United States
        • Local Institution
    • Georgia
      • Atlanta, Georgia, United States
        • Local Institution
      • Decatur, Georgia, United States
        • Local Institution
      • Jesup, Georgia, United States
        • Local Institution
      • Macon, Georgia, United States
        • Local Institution
      • Tucker, Georgia, United States
        • Local Institution
    • Hawaii
      • Honolulu, Hawaii, United States
        • Local Institution
      • Kahului, Hawaii, United States
        • Local Institution
    • Illinois
      • Chicago, Illinois, United States
        • Local Institution
      • Chicago, Illinois, United States, 60610
        • Local Institution
      • Joliet, Illinois, United States
        • Local Institution
      • Springfield, Illinois, United States
        • Local Institution
    • Indiana
      • Evansville, Indiana, United States
        • Local Institution
      • Munster, Indiana, United States
        • Local Institution
    • Kansas
      • Kansas City, Kansas, United States
        • Local Institution
      • Topeka, Kansas, United States
        • Local Institution
    • Kentucky
      • Paducah, Kentucky, United States
        • Local Institution
    • Louisiana
      • New Orleans, Louisiana, United States
        • Local Institution
    • Maine
      • Portland, Maine, United States
        • Local Institution
    • Maryland
      • Baltimore, Maryland, United States
        • Local Institution
      • Bethesda, Maryland, United States
        • Local Institution
    • Massachusetts
      • Boston, Massachusetts, United States
        • Local Institution
      • Hyannis, Massachusetts, United States
        • Local Institution
      • Provincetown, Massachusetts, United States
        • Local Institution
      • Springfield, Massachusetts, United States
        • Local Institution
    • Michigan
      • Berkley, Michigan, United States
        • Local Institution
      • Grand Rapids, Michigan, United States
        • Local Institution
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Local Institution
      • Rochester, Minnesota, United States
        • Local Institution
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Local Institution
      • St. Louis, Missouri, United States
        • Local Institution
    • Nevada
      • Las Vegas, Nevada, United States
        • Local Institution
      • Reno, Nevada, United States
        • Local Institution
    • New Jersey
      • Camden, New Jersey, United States
        • Local Institution
      • Elizabeth, New Jersey, United States
        • Local Institution
      • Englewood, New Jersey, United States
        • Local Institution
      • Hackensack, New Jersey, United States
        • Local Institution
      • Hoboken, New Jersey, United States
        • Local Institution
      • Neptune, New Jersey, United States
        • Local Institution
      • Newark, New Jersey, United States
        • Local Institution
      • Union, New Jersey, United States
        • Local Institution
      • Voorhees, New Jersey, United States
        • Local Institution
      • West Orange, New Jersey, United States
        • Local Institution
      • Westfield, New Jersey, United States
        • Local Instituton
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Local Institution
      • Santa Fe, New Mexico, United States
        • Local Institution
    • New York
      • Bronx, New York, United States
        • Local Institution
      • Brooklyn, New York, United States
        • Local Institution
      • Elmira, New York, United States
        • Local Institution
      • Mount Vernon, New York, United States
        • Local Institution
      • New Hyde Park, New York, United States
        • Local Institution
      • New York, New York, United States
        • Local Institution
      • Rochester, New York, United States
        • Local Institution
      • Southampton, New York, United States
        • Local Institution
      • Valhalla, New York, United States
        • Local Institution
    • North Carolina
      • Asheville, North Carolina, United States
        • Local Institution
      • Charlotte, North Carolina, United States
        • Local Institution
      • Greenville, North Carolina, United States
        • Local Institution
      • Huntersville, North Carolina, United States
        • Local Institution
      • Washington, North Carolina, United States
        • Local Institution
      • Winston-Salem, North Carolina, United States
        • Local Institution
    • Ohio
      • Akron, Ohio, United States, 44302
        • Local Institution
      • Cleveland, Ohio, United States
        • Local Institution
      • Columbus, Ohio, United States
        • Local Institution
    • Oregon
      • Portland, Oregon, United States, 97201-3098
        • Local Institution
    • Pennsylvania
      • Allentown, Pennsylvania, United States
        • Local Institution
      • Lancaster, Pennsylvania, United States
        • Local Institution
      • Philadelphia, Pennsylvania, United States
        • Local Institution
      • West Reading, Pennsylvania, United States
        • Local Institution
      • York, Pennsylvania, United States
        • Local Institution
    • Rhode Island
      • Providence, Rhode Island, United States
        • Local Institution
    • South Carolina
      • Columbia, South Carolina, United States
        • Local Institution
    • Tennessee
      • Knoxville, Tennessee, United States
        • Local Institution
      • Nashville, Tennessee, United States
        • Local Institution
    • Texas
      • Austin, Texas, United States
        • Local Institution
      • Corpus Christi, Texas, United States
        • Local Institution
      • Dallas, Texas, United States, 75205
        • Local Institution
      • El Paso, Texas, United States
        • Local Institution
      • Fort Worth, Texas, United States, 76104
        • Local Institution
      • Harlingen, Texas, United States
        • Local Institution
      • Houston, Texas, United States
        • Local Institution
      • San Antonio, Texas, United States
        • Local Institution
      • Tyler, Texas, United States, 75701
        • Local Institution
    • Virginia
      • Fairfax, Virginia, United States
        • Local Institution
      • Newport News, Virginia, United States
        • Local Institution
      • Norfolk, Virginia, United States
        • Local Institution
      • Richmond, Virginia, United States
        • Local Institution
      • Roanoke, Virginia, United States
        • Local Institution
    • Washington
      • Olympia, Washington, United States
        • Local Institution
      • Seattle, Washington, United States
        • Local Institution
      • Spokane, Washington, United States
        • Local Institution
    • Wisconsin
      • La Crosse, Wisconsin, United States
        • Local Institution
      • Madison, Wisconsin, United States
        • Local Institution
      • Madison, Wisconsin, United States, 53792
        • Local Institution
      • Milwaukee, Wisconsin, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2002

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2003

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2002

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2002

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2002

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AI424-900

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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