Safety Study of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00144287
First received: September 2, 2005
Last updated: November 4, 2013
Last verified: November 2013

September 2, 2005
November 4, 2013
May 2004
April 2006   (final data collection date for primary outcome measure)
  • The frequency of treatment-emergent adverse events (AEs), all serious AEs, and additional safety laboratory parameters
  • The occurrence of PI class-specific AEs, such as hemorrhage, dyslipidemia, hepatic events, hyperglycemia, pancreatitis, and rash
  • The occurrence of PI class-specific AEs , such as hemorrhage, dyslipidemia, hepatic events, hyperglycemia, pancreatitis, and rash.
  • The frequency of treatment-emergent Adverse Events (AE) , all Serious AE, and additional safety laboratory parameters.
Complete list of historical versions of study NCT00144287 on ClinicalTrials.gov Archive Site
  • The quantity of HIV-1 RNA
  • The CD4 cell count
  • o The quantity of HIV-1 RNA
  • o The CD4 cell count
Not Provided
Not Provided
 
Safety Study of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options
An Open Label Safety Study of Tipranavir Co-Administered With Low-Dose Ritonavir (TVP/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options

This study evaluated the safety and tolerability of tipranavir to improve treatment options for HIV type 1-infected patients who have been previously treated and whose treatment is no longer effective.

The purpose of this open label study is to assess the safety and tolerability of tipranavir co-administered with low-dose ritonavir (500 mg tipranavir/200 mg ritonavir BID) in HIV-1 infected patients who are triple antiretroviral class experienced with at least two previous PI-containing regimens.

The safety assessment will be performed by evaluating:

  • The frequency of treatment-emergent adverse events (AEs) , all serious adverse events (SAEs), and additional safety laboratory parameters.
  • The occurrence of PI class-specific AEs, such as hemorrhage, dyslipidemia, hepatic events, hyperglycemia, pancreatitis, and rash.

The efficacy assessment will be performed by evaluating:

  • The quantity of HIV-1 RNA
  • The CD4 cell count.

Study Hypothesis:

The purpose of this open label study is to assess the safety and tolerability of tipranavir co-administered with low-dose ritonavir (500 mg tipranavir/200 mg ritonavir BID) in HIV-1 infected patients who are triple antiretroviral class experienced with at least two previous PI-containing regimens.

Comparison(s):

N.A.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Tipranavir/Ritonavir
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
255
April 2006
April 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Triple antiretroviral class experienced patients with at least two previous PI-based regimens, who had failed or are intolerant to currently approved HIV-1 treatments
  2. Age >= 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(s) which, in the opinion of the investigator, would interfere with the patient´s ability to participate in or adhere to the requirements of this protocol.
  5. Use of other investigational drugs, within 30 days prior to TPV/r initiation and for the duration of study participation.
  6. Hepatic impairment(*) evidenced by the following baseline laboratory findings:

    • AST or ALT >5X upper limit of normal (ULN) or total bilirubin >3.5X ULN or
    • AST or ALT >2.5X ULN and total bilirubin >2X ULN

(*) Patients with liver enzymes outside this range will be restricted from participation in this safety study until more data become available from ongoing phase III clinical studies.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00144287
1182.68
Not Provided
Not Provided
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Pharma GmbH & Co. KG
Boehringer Ingelheim
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP