search
Back to results

Atazanavir for HIV Infected Individuals: An Early Access Program

Primary Purpose

HIV Infections

Status
No longer available
Phase
Locations
International
Study Type
Expanded Access
Intervention
Atazanavir (BMS-232632)
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for HIV Infections focused on measuring treatment experienced

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • LOcal Instituton
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Instituton
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 26, 2002
Last Updated
April 13, 2011
Sponsor
Bristol-Myers Squibb
search

1. Study Identification

Unique Protocol Identification Number
NCT00046345
Brief Title
Atazanavir for HIV Infected Individuals: An Early Access Program
Study Type
Expanded Access

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
No longer available
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
treatment experienced

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atazanavir (BMS-232632)

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

Atazanavir for HIV Infected Individuals: An Early Access Program

We'll reach out to this number within 24 hrs