NCT00046345

Brief 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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2002

Geographic Reach
2 countries

165 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2002

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
Last Updated

April 14, 2011

Status Verified

April 1, 2011

First QC Date

September 26, 2002

Last Update Submit

April 13, 2011

Conditions

Keywords

treatment experienced

Interventions

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (165)

Local Institution

Hobson City, Alabama, 36201, United States

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Anchorage, Alaska, 99508, 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, 92708, 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, 90022, 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, 80204, 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, 32608, 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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LOcal Instituton

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, 60610, 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, 64111, 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, 44302, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Portland, Oregon, 97201-3098, 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, 75205, United States

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El Paso, Texas, United States

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Fort Worth, Texas, 76104, 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, 75701, 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, 53792, 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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MeSH Terms

Conditions

HIV Infections

Interventions

Atazanavir Sulfate

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 26, 2002

First Posted

September 30, 2002

Study Start

May 1, 2002

Study Completion

July 1, 2003

Last Updated

April 14, 2011

Record last verified: 2011-04

Locations