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Tipranavir Expanded Access Program (EAP) in PI-experienced Patients With HIV-1 Infection

Primary Purpose

HIV Infections

Status
Approved for marketing
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Tipranavir
Ritonavir
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for HIV Infections

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)

Sites / Locations

  • 1182.70.127 Health Services Center, Inc.
  • 1182.70.006 Spectrum Medical Group
  • 1182.70.016 Health for Life Clinic
  • 1182.70.065
  • 1182.70.246
  • 1182.70.043
  • 1182.70.092
  • 1182.70.057
  • 1182.70.064
  • 1182.70.079
  • 1182.70.015
  • 1182.70.053
  • 1182.70.066
  • 1182.70.071
  • 1182.70.137
  • 1182.70.198
  • 1182.70.008
  • 1182.70.081
  • 1182.70.095
  • 1182.70.067
  • 1182.70.033
  • 1182.70.014
  • 1182.70.020
  • 1182.70.048
  • 1182.70.085
  • 1182.70.214
  • 1182.70.022
  • 1182.70.222
  • 1182.70.005
  • 1182.70.030
  • 1182.70.068
  • 1182.70.218 Denver Infectious Disease Consultants
  • 1182.70.281
  • 1182.70.074
  • 1182.70.073
  • 1182.70.032
  • 1182.70.042
  • 1182.70.289 Dupont Circle Physicians Group
  • 1182.70.003
  • 1182.70.013
  • 1182.70.049
  • 1182.70.096
  • 1182.70.045
  • 1182.70.026
  • 1182.70.023
  • 1182.70.040
  • 1182.70.007
  • 1182.70.117
  • 1182.70.017
  • 1182.70.047
  • 1182.70.002
  • 1182.70.046
  • 1182.70.069
  • 1182.70.037
  • 1182.70.058
  • 1182.70.174
  • 1182.70.019
  • 1182.70.029 Dr. David Moore
  • 1182.70.194
  • 1182.70.010
  • 1182.70.167
  • 1182.70.192
  • 1182.70.099
  • 1182.70.025 Chase Brexton Health Services, Inc
  • 1182.70.082
  • 1182.70.090
  • 1182.70.004
  • 1182.70.084
  • 1182.70.035
  • 1182.70.242
  • 1182.70.093
  • 1182.70.021
  • 1182.70.288 Hackensack University Medical Center
  • 1182.70.075
  • 1182.70.024
  • 1182.70.105
  • 1182.70.250 Montefiore Medical Center
  • 1182.70.039
  • 1182.70.028
  • 1182.70.031
  • 1182.70.036
  • 1182.70.050
  • 1182.70.062
  • 1182.70.104
  • 1182.70.086 Boehringer Ingelheim Investigational Site
  • 1182.70.061
  • 1182.70.100
  • 1182.70.136 Mecklenburg Medical Group, P.A.
  • 1182.70.103
  • 1182.70.241 University of CIncinnati Medical Center
  • 1182.70.044
  • 1182.70.059 Fanno Creek Clinic
  • 1182.70.077 Kaiser Permanente-IDC
  • 1182.70.051
  • 1182.70.080
  • 1182.70.072
  • 1182.70.126
  • 1182.70.271
  • 1182.70.088
  • 1182.70.165 Comprehensive Care Center
  • 1182.70.018
  • 1182.70.038
  • 1182.70.041
  • 1182.70.055
  • 1182.70.070
  • 1182.70.060
  • 1182.70.052
  • 1182.70.054
  • 1182.70.285
  • 1182.70.128 Olmos Park Medical Associates
  • 1182.70.011
  • 1182.70.217
  • 1182.70.097
  • 1182.70.76
  • 1182.70.083

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 30, 2004
Last Updated
November 29, 2016
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00097799
Brief Title
Tipranavir Expanded Access Program (EAP) in PI-experienced Patients With HIV-1 Infection
Official Title
An Open Label, Non-randomized Treatment Protocol of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Protease Inhibitor-experienced Patients With HIV-1 Infection (the Tipranavir Expanded Access Program)
Study Type
Expanded Access

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Approved for marketing
Study Start Date
December 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
This study was designed to provide early access to and evaluate the safety of TPV/r in PI-experienced patients with HIV-1 infection.

6. Conditions and Keywords

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

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tipranavir
Intervention Description
500 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Description
200 mg twice daily

10. Eligibility

Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1182.70.127 Health Services Center, Inc.
City
Anniston
State/Province
Alabama
Country
United States
Facility Name
1182.70.006 Spectrum Medical Group
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
1182.70.016 Health for Life Clinic
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
1182.70.065
City
Anaheim
State/Province
California
Country
United States
Facility Name
1182.70.246
City
Baldwin Park
State/Province
California
Country
United States
Facility Name
1182.70.043
City
Fountain Valley
State/Province
California
Country
United States
Facility Name
1182.70.092
City
Fresno
State/Province
California
Country
United States
Facility Name
1182.70.057
City
Glendale
State/Province
California
Country
United States
Facility Name
1182.70.064
City
Harbor City
State/Province
California
Country
United States
Facility Name
1182.70.079
City
Long Beach
State/Province
California
Country
United States
Facility Name
1182.70.015
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1182.70.053
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1182.70.066
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1182.70.071
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1182.70.137
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1182.70.198
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1182.70.008
City
Newport Beach
State/Province
California
Country
United States
Facility Name
1182.70.081
City
Oakland
State/Province
California
Country
United States
Facility Name
1182.70.095
City
Oakland
State/Province
California
Country
United States
Facility Name
1182.70.067
City
Panorama City
State/Province
California
Country
United States
Facility Name
1182.70.033
City
San Diego
State/Province
California
Country
United States
Facility Name
1182.70.014
City
San Francisco
State/Province
California
Country
United States
Facility Name
1182.70.020
City
San Francisco
State/Province
California
Country
United States
Facility Name
1182.70.048
City
San Francisco
State/Province
California
Country
United States
Facility Name
1182.70.085
City
San Francisco
State/Province
California
Country
United States
Facility Name
1182.70.214
City
San Francisco
State/Province
California
Country
United States
Facility Name
1182.70.022
City
San Rafael
State/Province
California
Country
United States
Facility Name
1182.70.222
City
Stanford
State/Province
California
Country
United States
Facility Name
1182.70.005
City
Tarzana
State/Province
California
Country
United States
Facility Name
1182.70.030
City
Tarzana
State/Province
California
Country
United States
Facility Name
1182.70.068
City
Woodland Hills
State/Province
California
Country
United States
Facility Name
1182.70.218 Denver Infectious Disease Consultants
City
Denver
State/Province
Colorado
Country
United States
Facility Name
1182.70.281
City
Denver
State/Province
Colorado
Country
United States
Facility Name
1182.70.074
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
1182.70.073
City
Norwich
State/Province
Connecticut
Country
United States
Facility Name
1182.70.032
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
1182.70.042
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
1182.70.289 Dupont Circle Physicians Group
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
1182.70.003
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
1182.70.013
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
1182.70.049
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
1182.70.096
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
1182.70.045
City
Fort Myers
State/Province
Florida
Country
United States
Facility Name
1182.70.026
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
1182.70.023
City
Miami
State/Province
Florida
Country
United States
Facility Name
1182.70.040
City
North Palm Beach
State/Province
Florida
Country
United States
Facility Name
1182.70.007
City
Orlando
State/Province
Florida
Country
United States
Facility Name
1182.70.117
City
Plantation
State/Province
Florida
Country
United States
Facility Name
1182.70.017
City
Pompano Beach
State/Province
Florida
Country
United States
Facility Name
1182.70.047
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
1182.70.002
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
1182.70.046
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
1182.70.069
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
1182.70.037
City
Dactur
State/Province
Georgia
Country
United States
Facility Name
1182.70.058
City
Jesup
State/Province
Georgia
Country
United States
Facility Name
1182.70.174
City
Macon
State/Province
Georgia
Country
United States
Facility Name
1182.70.019
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
1182.70.029 Dr. David Moore
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
1182.70.194
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
1182.70.010
City
Joliet
State/Province
Illinois
Country
United States
Facility Name
1182.70.167
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
1182.70.192
City
Iowa City
State/Province
Iowa
Country
United States
Facility Name
1182.70.099
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
1182.70.025 Chase Brexton Health Services, Inc
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
1182.70.082
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
1182.70.090
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
1182.70.004
City
Berkley
State/Province
Michigan
Country
United States
Facility Name
1182.70.084
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
1182.70.035
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
1182.70.242
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
1182.70.093
City
Lincoln
State/Province
Nebraska
Country
United States
Facility Name
1182.70.021
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
1182.70.288 Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
Country
United States
Facility Name
1182.70.075
City
Sommers Point
State/Province
New Jersey
Country
United States
Facility Name
1182.70.024
City
Briarcliff Manor
State/Province
New York
Country
United States
Facility Name
1182.70.105
City
Bronk
State/Province
New York
Country
United States
Facility Name
1182.70.250 Montefiore Medical Center
City
Bronx
State/Province
New York
Country
United States
Facility Name
1182.70.039
City
Kingston
State/Province
New York
Country
United States
Facility Name
1182.70.028
City
New York
State/Province
New York
Country
United States
Facility Name
1182.70.031
City
New York
State/Province
New York
Country
United States
Facility Name
1182.70.036
City
New York
State/Province
New York
Country
United States
Facility Name
1182.70.050
City
New York
State/Province
New York
Country
United States
Facility Name
1182.70.062
City
New York
State/Province
New York
Country
United States
Facility Name
1182.70.104
City
New York
State/Province
New York
Country
United States
Facility Name
1182.70.086 Boehringer Ingelheim Investigational Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
1182.70.061
City
Asheville
State/Province
North Carolina
Country
United States
Facility Name
1182.70.100
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
1182.70.136 Mecklenburg Medical Group, P.A.
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
1182.70.103
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
1182.70.241 University of CIncinnati Medical Center
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
1182.70.044
City
Portland
State/Province
Oregon
Country
United States
Facility Name
1182.70.059 Fanno Creek Clinic
City
Portland
State/Province
Oregon
Country
United States
Facility Name
1182.70.077 Kaiser Permanente-IDC
City
Portland
State/Province
Oregon
Country
United States
Facility Name
1182.70.051
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
1182.70.080
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
1182.70.072
City
Providence
State/Province
Rhode Island
Country
United States
Facility Name
1182.70.126
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
1182.70.271
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
1182.70.088
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
1182.70.165 Comprehensive Care Center
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
1182.70.018
City
Austin
State/Province
Texas
Country
United States
Facility Name
1182.70.038
City
Dallas
State/Province
Texas
Country
United States
Facility Name
1182.70.041
City
Dallas
State/Province
Texas
Country
United States
Facility Name
1182.70.055
City
Dallas
State/Province
Texas
Country
United States
Facility Name
1182.70.070
City
Dallas
State/Province
Texas
Country
United States
Facility Name
1182.70.060
City
El Paso
State/Province
Texas
Country
United States
Facility Name
1182.70.052
City
Houston
State/Province
Texas
Country
United States
Facility Name
1182.70.054
City
Houston
State/Province
Texas
Country
United States
Facility Name
1182.70.285
City
Houston
State/Province
Texas
Country
United States
Facility Name
1182.70.128 Olmos Park Medical Associates
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
1182.70.011
City
Annadale
State/Province
Virginia
Country
United States
Facility Name
1182.70.217
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
1182.70.097
City
Seattle
State/Province
Washington
Country
United States
Facility Name
1182.70.76
City
Seattle
State/Province
Washington
Country
United States
Facility Name
1182.70.083
City
Spokane
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1182/1182.70.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1182/1182.70_literature.pdf
Description
Related Info

Learn more about this trial

Tipranavir Expanded Access Program (EAP) in PI-experienced Patients With HIV-1 Infection

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