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Home > "A" Clinical Trials Conditions > Atazanavir for HIV Infected Individuals: An Early Access Program  Atazanavir for HIV Infected Individuals: An Early Access Program
Atazanavir for HIV Infected Individuals: An Early Access Program
For Condition: HIV Infections
Status: Completed
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
Local Institution
Phoenix, Arizona,
United States
Local Institution
Valhalla, New York,
United States
Local Institution
Elmira, New York,
United States
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Brooklyn, New York,
United States
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El Cajon, California,
United States
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Topeka, Kansas,
United States
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Harlingen, Texas,
United States
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Key West, Florida,
United States
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Baltimore, Maryland,
United States
Local Institution
Fountain Valley, California, 92708
United States
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Beverly Hills, California,
United States
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Honolulu, Hawaii,
United States
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Camden, New Jersey,
United States
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Norfolk, Virginia,
United States
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Scottsdale, Arizona,
United States
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Paducah, Kentucky,
United States
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York, Pennsylvania,
United States
Local Institution
Akron, Ohio, 44302
United States
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Bronx, New York,
United States
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Grand Rapids, Michigan,
United States
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Denver, Colorado, 80204
United States
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Minneapolis, Minnesota,
United States
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Hackensack, New Jersey,
United States
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Meriden, Connecticut,
United States
Local Instituton
Westfield, New Jersey,
United States
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Hoboken, New Jersey,
United States
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Newark, New Jersey,
United States
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Rochester, New York,
United States
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New York City, New York,
United States
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Vero Beach, Florida,
United States
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Ft. Myers, Florida,
United States
Local Institution
Springfield, Massachusetts,
United States
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Rio Piedras, ,
Puerto Rico
Local Institution
Anchorage, Alaska, 99508
United States
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Greenville, North Carolina,
United States
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Tarzana, California,
United States
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Sacramento, California,
United States
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Boston, Massachusetts,
United States
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Roanoke, Virginia,
United States
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Philadelphia, Pennsylvania,
United States
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Asheville, North Carolina,
United States
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Olympia, Washington,
United States
Local Institution
Kansas City, Missouri, 64111
United States
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Union, New Jersey,
United States
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Daytona Beach, Florida,
United States
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Nashville, Tennessee,
United States
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Madison, Wisconsin,
United States
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Paramount, California,
United States
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Albuquerque, New Mexico,
United States
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Allentown, Pennsylvania,
United States
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Fairfield, California,
United States
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West Hills, California,
United States
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Washington D.C., District of Columbia,
United States
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North, Florida,
United States
Local Institution
Columbus, Ohio,
United States
Local Institution
Munster, Indiana,
United States
Local Institution
West Orange, New Jersey,
United States
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New Orleans, Louisiana,
United States
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Wheat Ridge, Colorado,
United States
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Hobson City, Alabama, 36201
United States
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Bakersfield, California,
United States
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Portland, Maine,
United States
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Macon, Georgia,
United States
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Glendale, California,
United States
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Reno, Nevada,
United States
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San Antonio, Texas,
United States
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Harbor City, California,
United States
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Hollywood, Florida,
United States
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Ft. Lauderdale, Florida,
United States
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Berkley, Michigan,
United States
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Sherman Oaks, California,
United States
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Norwalk, Connecticut,
United States
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Bradenton, Florida,
United States
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Santa Rosa, California,
United States
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Altamonte Springs, Florida,
United States
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San Bernardino, California,
United States
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Woodland Hills, California,
United States
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Palm Springs, California,
United States
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Winter Haven, Florida,
United States
Local Institution
Gainesville, Florida, 32608
United States
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Hartford, Connecticut,
United States
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Dallas, Texas, 75205
United States
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San Jose, California,
United States
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Plantation, Florida,
United States
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Lancaster, Pennsylvania,
United States
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Madison, Wisconsin, 53792
United States
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St. Louis, Missouri,
United States
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Miami, Florida,
United States
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Springfield, Massachusetts,
United States
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Voorhees, New Jersey,
United States
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Seattle, Washington,
United States
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Houston, Texas,
United States
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New Hyde Park, New York,
United States
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Sunnyvale, California,
United States
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Fontana, California,
United States
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Las Vegas, Nevada,
United States
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Atlanta, Georgia,
United States
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Neptune, New Jersey,
United States
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Washington, North Carolina,
United States
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Chicago, Illinois,
United States
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Charlotte, North Carolina,
United States
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Corpus Christi, Texas,
United States
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Newport News, Virginia,
United States
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San Rafael, California,
United States
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Huntersville, North Carolina,
United States
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Cleveland, Ohio,
United States
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Kahului, Hawaii,
United States
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Los Angeles, California, 90022
United States
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Norwalk, Connecticut,
United States
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Winston Salem, North Carolina,
United States
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Santa Fe, New Mexico,
United States
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Jesup, Georgia,
United States
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Oakland, California,
United States
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Portland, Oregon, 97201-3098
United States
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Decatur, Georgia,
United States
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Hyannis, Massachusetts,
United States
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Oakland Park, Florida,
United States
Local Institution
Kansas City, Kansas,
United States
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Tampa, Florida,
United States
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San Diego, California,
United States
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Mill Valley, California,
United States
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Knoxville, Tennessee,
United States
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Pensacola, Florida,
United States
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Southampton, New York,
United States
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Santa Ana, California,
United States
Local Institution
Bay Pines, Florida,
United States
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Pompano Beach, Florida,
United States
Local Institution
Rockville, Connecticut,
United States
Local Institution
Ft. Worth, Texas, 76104
United States
Local Institution
Elizabeth, New Jersey,
United States
local Institution
Fairfax, Virginia,
United States
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Palo Alto, California,
United States
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West Reading, Pennsylvania,
United States
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Tucker, Georgia,
United States
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Spokane, Washington,
United States
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Panorama City, California,
United States
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San Francisco, California,
United States
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El Paso, Texas,
United States
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Providence, Rhode Island,
United States
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Newport Beach, California,
United States
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Richmond, Virginia,
United States
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Berkeley, California,
United States
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Long Beach, California,
United States
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Rochester, Minnesota,
United States
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Austin, Texas,
United States
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Evansville, Indiana,
United States
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Tucson, Arizona,
United States
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Lancaster, California,
United States
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Englewood, New Jersey,
United States
Local Institution
Little Rock, Arkansas,
United States
Local Institution
Provincetown, Massachusetts,
United States
Local Institution
Tyler, Texas, 75701
United States
Local Institution
Springfield, Illinois,
United States
LOcal Instituton
Sarasota, Florida,
United States
Local Institution
Mount Vernon, New York,
United States
Local Institution
Jacksonville, Florida,
United States
Local Institution
Chicago, Illinois, 60610
United States
Local Institution
Bethesda, Maryland,
United States
Local Institution
Ponce, ,
Puerto Rico
Local Institution
Columbia, South Carolina,
United States
Local Institution
San Mateo, California,
United States
Local Institution
Winter Park, Florida,
United States
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Miami, Florida,
United States
Local Institution
Miami, Florida,
United States
Local Institution
Bay Pines, Florida,
United States
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Milwaukee, Wisconsin,
United States
Local Institution
Joliet, Illinois,
United States
Local Institution
La Crosse, Wisconsin,
United States
Additional Information:
Study ID Numbers: AI424-900;
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00046345
Other Hiv Infections Studies:
1. Safety and Effectiveness of the Drug DPC 083 in Combination with Nucleoside Analogue Reverse Transcriptase Inhibitors in HIV-1-Infected Patients Who Are Failing Treatment with Nonnucleoside Reverse Transcriptase Inhibitors
2. Safety and Effectiveness of Azidothymidine (AZT) in HIV-Positive Patients with Hemophilia
3. An Open-Label Study to Evaluate the Efficacy and Safety of Amprenavir (141W94) and Abacavir Combination Therapy in Protease Inhibitor Experienced Subjects with HIV-1 Infection Who Are Failing Their Current Antiretroviral Treatment Regimen
4. Growth Hormone in the Treatment of HIV-Associated Wasting
5. A Phase I Clinical Trial to Evaluate: Part A. The Safety of MTP-PE/MF59 Adjuvant Emulsion. Part B. The Safety and Immunogenicity of Env 2-3, a Yeast Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59
Related Studies:
Other HIV Infections Clinical Trials
Other North Carolina Clinical Trials
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Atazanavir for HIV Infected Individuals: An Early Access Program
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