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An Open Label Safety Study of Tipranavir Co-administered With Low-dose Ritonavir in Patients With Advanced HIV-1 Infection and Limited Treatment Options.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00933205
Expanded Access Status : Approved for marketing
First Posted : July 7, 2009
Last Update Posted : November 30, 2016
Sponsor:
Information provided by:
Boehringer Ingelheim

Brief Summary:
The purpose of this Open Label Safety Study is to provide access to and evaluate the safety and tolerability of TPV/r in treatment-experienced patients with advanced HIV-1 infection who have failed at least two PI-containing regimens, and have limited treatment options.

Condition or disease Intervention/treatment
HIV Infections Drug: Tipranavir

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Study Type : Expanded Access
Official Title: An Open Label Safety Study of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options.
Study Start Date : May 2004
Actual Primary Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Tipranavir



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Triple anti-retroviral class experienced patients with at least 2 previous PI-based regimens who had failed or are intolerant to currently approved HIV-1 treatments.
  2. Age equal or more than 18 years
  3. Patient is willing to use an effective barrier method of contraception for the duration of study participation and up to three months thereafter
  4. Patient voluntarily provides written informed consent to participate, in compliance with local law.

Exclusion Criteria:

  1. Hypersensitivity to active ingredients or any of the excipients in tipranavir or ritonavir
  2. Required use of restricted medications.
  3. Female patients of childbearing potential who have a positive pregnancy test at baseline or are breast feeding.
  4. Any medical condition which in the opinion of the investigator would interfere with the patients' ability to participate in or adhere to the requirements of this protocol.
  5. Use of other investigational drugs, within 30 days prior to TPV boosted with ritonavir initiation and for the duration of study participation
  6. Hepatic impairment evidenced by the following baseline laboratory findings:

    • AST or ALT more than 5X ULN or total bilirubin more than 3.5X ULN
    • AST or ALT more 2.5X ULN and total bilirubin more 2X ULN

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00933205


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
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Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00933205    
Other Study ID Numbers: 1182.16
First Posted: July 7, 2009    Key Record Dates
Last Update Posted: November 30, 2016
Last Verified: October 2013
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Tipranavir
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents