Official Title
An Open Label Safety Study to Evaluate the Safety of Tipranavir Plus Ritonavir When Used in Combination With Other Agents for the Treatment of Patients With HIV Infection Who Have Failed and/or Are Intolerant to Combination Antiretroviral Therapy and Have Limited Treatment Options
Brief Summary

To provide early access to tipranavir and evaluate the safety and tolerance of tipranavir combined with low dose of ritonavir in patients with progressive, HIV-1 disease who have failed or are intolerant to currently approved treatments for HIV infection, who are unable to participate in another tipranavir controlled clinical trial and have an urgent need for anti-HIV treatment.

Status
Approved for marketing
Conditions
HIV Infections
Interventions

Drug: Tipranavir
Tipranavir 250 mg soft elastic capsules

Eligibility Criteria

Inclusion criteria:

Patients aho have a positive serology HIV antibody test confirmed by Western blot, p24
antigen assay, HIV-1 RNA or HIV culture and are highly pre-treated and virus resistant to
multiple protease inhibitors.

Eligibility Gender
All
Eligibility Age
Minimum: 2 Years
Countries
Australia
Belgium
Denmark
France
Greece
Ireland
Italy
Portugal
South Africa
Switzerland
United Kingdom
United States
Locations

1182.58.31
Scottsdale, Arizona,

1182.58.29
Los Angeles, California,

1182.58.34 Campus Code 696446
Los Angeles, California,

1182.58.42 Synergy Hematology/Oncology
Los Angeles, California,

1182.58.43
Los Angeles, California,

1182.58.03
San Francisco, California,

1182.58.33 Kaiser Permanente Medical Center, Clinical Trials Unit
San Francisco, California,

1182.58.37 AIDS Health Care Foundation
Los Angeles, Connecticut,

1182.58.41 Circle Medical, LLC
Norwalk, Connecticut,

1182.58.28
Washington, District of Columbia,

1182.58.38
Miami Beach, Florida,

1182.58.40 Drs. Raben and Feldman Research Associates
South Miami, Florida,

1182.58.23 Hillsborough County Health Department
Tampa, Florida,

1182.58.36 Suite 525
Atlanta, Georgia,

1182.58.08
Honolulu, Hawaii,

1182.58.22
Chicago, Illinois,

1182.58.32
New Orleans, Louisiana,

1182.58.15
Boston, Massachusetts,

1182.58.19 Henry Ford Hospital
Detroit, Michigan,

1182.58.04 Kansas City Free Health Clinic
Kansas City, Missouri,

1182.58.25 Wohl Clinic
St. Louis, Missouri,

1182.58.02 Wellness Center
Las Vegas, Nevada,

1182.58.09 Polari Medical Group
New York, New York,

1182.58.30
Chapel Hill, North Carolina,

1182.58.06 University of Cincinnati Medical Center, Infectious diseases
Cincinnati, Ohio,

1182.58.35
Portland, Oregon,

1182.58.14
Philadelphia, Pennsylvania,

1182.58.20 University of Pittsburgh
Pittsburgh, Pennsylvania,

1182.58.01 Boehringer Ingelheim Investigational Site
Columbia, South Carolina,

1182.58.10 Comprehensive Care Center
Nashville, Tennessee,

1182.58.18 University of Texas Southwest Medical Center at Dallas
Dallas, Texas,

1182.58.07
Houston, Texas,

1182.58.039 Olmos Park Medical Associates
San Antonio, Texas,

1182.58.11 Swedish Medical Center
Seattle, Washington,

1182.58.44 VW Hospital and Clinics
Madison, Wisconsin,

Investigators

Boehringer Ingelheim
Study Chair
Boehringer Ingelheim

Sponsors / Collaborators
Boehringer Ingelheim
NCT Number
NCT00062660
MeSH Terms
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Tipranavir