HIV InfectionsNCT00046345

Atazanavir for HIV Infected Individuals: An Early Access Program

A study testing Atazanavir (BMS-232632) in people with HIV Infections, run by Bristol-Myers Squibb at 165 sites in 2 countries.

No Longer Available

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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… Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: HIV Infections
What is being tested?: Atazanavir (BMS-232632)
How many people: Not given
Where: 165 sitesin 2 countries
Study dates: May 2002to Jul 2003
Phase: Expanded access
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

165 sites in 2 countries.

Country

City, postcode or hospital

165 sites in 2 countries

United States163 sites

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Akron, Ohio, 44302
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Albuquerque, New Mexico
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Allentown, Pennsylvania
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Altamonte Springs, Florida
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Anchorage, Alaska, 99508
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Asheville, North Carolina
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Atlanta, Georgia
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Austin, Texas
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Bakersfield, California
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Baltimore, Maryland
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Bay Pines, Florida
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Berkeley, California
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Berkley, Michigan
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Bethesda, Maryland
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Beverly Hills, California
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Boston, Massachusetts
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Bradenton, Florida
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Brooklyn, New York
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Camden, New Jersey
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Charlotte, North Carolina
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Chicago, Illinois, 60610
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Chicago, Illinois
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Cleveland, Ohio
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Columbia, South Carolina
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Columbus, Ohio
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Corpus Christi, Texas
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Dallas, Texas, 75205
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Daytona Beach, Florida
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Decatur, Georgia
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Denver, Colorado, 80204
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El Cajon, California
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El Paso, Texas
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Elizabeth, New Jersey
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Elmira, New York
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Englewood, New Jersey
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Evansville, Indiana
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Fairfax, Virginia
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Fairfield, California
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Fontana, California
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Fort Lauderdale, Florida
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Fort Myers, Florida
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Fort Worth, Texas, 76104
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Fountain Valley, California, 92708
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Gainesville, Florida, 32608
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Glendale, California
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Grand Rapids, Michigan
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Greenville, North Carolina
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Hackensack, New Jersey
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Harbor City, California
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Harlingen, Texas
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Hartford, Connecticut
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Hoboken, New Jersey
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Hobson City, Alabama, 36201
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Hollywood, Florida
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Honolulu, Hawaii
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Houston, Texas
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Huntersville, North Carolina
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Hyannis, Massachusetts
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Jacksonville, Florida
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Jesup, Georgia
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Joliet, Illinois
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Kahului, Hawaii
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Kansas City, Kansas
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Kansas City, Missouri, 64111
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Key West, Florida
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Knoxville, Tennessee
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La Crosse, Wisconsin
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Lancaster, California
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Lancaster, Pennsylvania
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Las Vegas, Nevada
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Little Rock, Arkansas
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Long Beach, California
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Los Angeles, California, 90022
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Macon, Georgia
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Madison, Wisconsin, 53792
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Madison, Wisconsin
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Meriden, Connecticut
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Miami, Florida
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Miami Beach, Florida
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Mill Valley, California
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Milwaukee, Wisconsin
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Minneapolis, Minnesota
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Mount Vernon, New York
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Munster, Indiana
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Nashville, Tennessee
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Neptune City, New Jersey
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New Hyde Park, New York
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New Orleans, Louisiana
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New York, New York
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Newark, New Jersey
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Newport Beach, California
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Newport News, Virginia
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Norfolk, Virginia
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North Miami Beach, Florida
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North Palm Beach, Florida
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Norwalk, Connecticut
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Oakland, California
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Oakland Park, Florida
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Olympia, Washington
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Paducah, Kentucky
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Palm Springs, California
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Palo Alto, California
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Panorama City, California
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Paramount, California
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Pensacola, Florida
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Plantation, Florida
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Pompano Beach, Florida
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Portland, Maine
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Portland, Oregon, 97201-3098
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Providence, Rhode Island
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Provincetown, Massachusetts
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Reno, Nevada
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Richmond, Virginia
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Roanoke, Virginia
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Rochester, Minnesota
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Rochester, New York
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Rockville, Connecticut
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Sacramento, California
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San Antonio, Texas
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San Bernardino, California
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San Diego, California
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San Francisco, California
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San Jose, California
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San Mateo, California
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San Rafael, California
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Santa Ana, California
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Santa Fe, New Mexico
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Santa Rosa, California
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Sarasota, Florida
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Scottsdale, Arizona
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Seattle, Washington
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Sherman Oaks, California
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Southampton, New York
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Spokane, Washington
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Springfield, Illinois
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Springfield, Massachusetts
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St Louis, Missouri
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Sunnyvale, California
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Tampa, Florida
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Tarzana, California
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The Bronx, New York
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Topeka, Kansas
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Tucker, Georgia
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Tucson, Arizona
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Tyler, Texas, 75701
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Union, New Jersey
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Valhalla, New York
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Vero Beach, Florida
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Voorhees Township, New Jersey
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Washington, North Carolina
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Washington D.C., District of Columbia
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West Hills, California
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West Orange, New Jersey
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West Reading, Pennsylvania
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Westfield, New Jersey
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Wheat Ridge, Colorado
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Winston-Salem, North Carolina
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Winter Haven, Florida
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Winter Park, Florida
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Woodland Hills, California
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York, Pennsylvania

Other trials in United States

Puerto Rico2 sites

Local Institution
Ponce
Local Institution
Rio Piedras

Other trials in Puerto Rico

About this study

Conditions: HIV Infections
Being tested: Atazanavir (BMS-232632)
Keywords: treatment experienced
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Atazanavir (BMS-232632)Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2002Jul 2003

First posted30 Sep 2002 (estimated)
Study startMay 2002
Study completionJul 2003

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Expanded access

IDs, dates and publications

ClinicalTrials.gov ID: NCT00046345
Sponsor's protocol ID: AI424-900
Status last verified: Apr 2011
First submitted: 26 Sep 2002
Last updated: 14 Apr 2011
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Atazanavir for HIV Infected Individuals: An Early Access Program
ClinicalTrials.gov ID: NCT00046345
Acronym / sponsor ID: AI424-900
Conditions: HIV Infections
Keywords: treatment experienced
Study type: Expanded access
Recruitment status: No Longer Available
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: May 2002
Study completion: Jul 2003
First posted: 30 Sep 2002 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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 (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Atazanavir (BMS-232632)	Drug	–

Primary outcome

Not reported in the source record.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2011.

Related trials for HIV Infections

Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
RecruitingObservational study
Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection
HIV
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
RecruitingPhase 1
AMC 120, Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma (The "Glofit-RCHOP Study")
AIDS-Related Diffuse Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

165 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Atazanavir (BMS-232632) in people with HIV Infections, run by Bristol-Myers Squibb at 165 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 165 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00046345.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2011.