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NCT00046345 Clinical Trial

Atazanavir for HIV Infected Individuals: An Early Access Program

HIV Infections Clinical Trial

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT00046345
Other study ID # AI424-900
Secondary ID
Status No longer available
Phase N/A
First received September 26, 2002
Last updated April 13, 2011
Start date May 2002
Est. completion date July 2003

Study information
Verified date April 2011
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date July 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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 Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• Atazanavir (BMS-232632)

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

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Puerto Rico, 

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