Atazanavir for HIV Infected Individuals: An Early Access Program

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: No longer available
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Atazanavir (BMS-232632)

• Study Type: Expanded Access

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: May 1, 2002
• Study Completion: July 1, 2003

Study Registration Dates

• First Submitted: September 26, 2002
• First Submitted That Met QC Criteria: September 27, 2002
• First Posted (Estimate): September 30, 2002

Study Record Updates

• Last Update Posted (Estimate): April 14, 2011
• Last Update Submitted That Met QC Criteria: April 13, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: treatment experienced
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Atazanavir Sulfate
• Other Study ID Numbers: AI424-900