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Atazanavir for HIV Infected Individuals: An Early Access Program

NCT ID: NCT00046345

Last Updated: 2011-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Study Start Date

2002-05-31

Study Completion Date

2003-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Interventions

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Atazanavir (BMS-232632)

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Locations

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Hobson City, Alabama, United States

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Anchorage, Alaska, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Bakersfield, California, United States

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Berkeley, California, United States

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Beverly Hills, California, United States

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El Cajon, California, United States

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Fairfield, California, United States

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Fontana, California, United States

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Fountain Valley, California, United States

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Glendale, California, United States

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Harbor City, California, United States

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Lancaster, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Mill Valley, California, United States

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Newport Beach, California, United States

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Oakland, California, United States

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Palm Springs, California, United States

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Palo Alto, California, United States

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Panorama City, California, United States

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Paramount, California, United States

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Sacramento, California, United States

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San Bernardino, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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San Jose, California, United States

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San Mateo, California, United States

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San Rafael, California, United States

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Santa Ana, California, United States

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Santa Rosa, California, United States

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Sherman Oaks, California, United States

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Sunnyvale, California, United States

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Tarzana, California, United States

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West Hills, California, United States

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Woodland Hills, California, United States

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Denver, Colorado, United States

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Wheat Ridge, Colorado, United States

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Hartford, Connecticut, United States

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Meriden, Connecticut, United States

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Norwalk, Connecticut, United States

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Rockville, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Altamonte Springs, Florida, United States

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Bay Pines, Florida, United States

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Bradenton, Florida, United States

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Daytona Beach, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Myers, Florida, United States

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Gainesville, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Key West, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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North Miami Beach, Florida, United States

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North Palm Beach, Florida, United States

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Oakland Park, Florida, United States

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Pensacola, Florida, United States

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Plantation, Florida, United States

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Pompano Beach, Florida, United States

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Sarasota, Florida, United States

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Tampa, Florida, United States

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Vero Beach, Florida, United States

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Winter Haven, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Jesup, Georgia, United States

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Macon, Georgia, United States

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Tucker, Georgia, United States

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Honolulu, Hawaii, United States

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Kahului, Hawaii, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Joliet, Illinois, United States

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Springfield, Illinois, United States

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Evansville, Indiana, United States

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Munster, Indiana, United States

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Kansas City, Kansas, United States

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Topeka, Kansas, United States

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Paducah, Kentucky, United States

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New Orleans, Louisiana, United States

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Portland, Maine, United States

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Baltimore, Maryland, United States

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Bethesda, Maryland, United States

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Boston, Massachusetts, United States

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Hyannis, Massachusetts, United States

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Provincetown, Massachusetts, United States

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Springfield, Massachusetts, United States

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Berkley, Michigan, United States

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Grand Rapids, Michigan, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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Camden, New Jersey, United States

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Elizabeth, New Jersey, United States

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Englewood, New Jersey, United States

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Hackensack, New Jersey, United States

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Hoboken, New Jersey, United States

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Neptune City, New Jersey, United States

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Newark, New Jersey, United States

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Union, New Jersey, United States

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Voorhees Township, New Jersey, United States

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West Orange, New Jersey, United States

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Westfield, New Jersey, United States

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Albuquerque, New Mexico, United States

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Santa Fe, New Mexico, United States

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Brooklyn, New York, United States

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Elmira, New York, United States

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Mount Vernon, New York, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Southampton, New York, United States

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The Bronx, New York, United States

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Valhalla, New York, United States

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Asheville, North Carolina, United States

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Charlotte, North Carolina, United States

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Greenville, North Carolina, United States

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Huntersville, North Carolina, United States

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Washington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Portland, Oregon, United States

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Allentown, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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York, Pennsylvania, United States

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Providence, Rhode Island, United States

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Columbia, South Carolina, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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El Paso, Texas, United States

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Fort Worth, Texas, United States

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Harlingen, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Tyler, Texas, United States

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Fairfax, Virginia, United States

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Newport News, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Roanoke, Virginia, United States

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Olympia, Washington, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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La Crosse, Wisconsin, United States

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Madison, Wisconsin, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Ponce, , Puerto Rico

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Rio Piedras, , Puerto Rico

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Countries

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United States Puerto Rico

Other Identifiers

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AI424-900

Identifier Type: -

Identifier Source: org_study_id

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