Safety Study of Tipranavir Co-Administered With Low-Dose Ritonavir (TPV/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options - Full Text View

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00144287

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Tipranavir/Ritonavir	Phase III

MedlinePlus related topics: AIDS

Drug Information available for: Ritonavir Tipranavir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	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

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

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

Secondary Outcome Measures:

The quantity of HIV-1 RNA
The CD4 cell count

Estimated Enrollment:	400
Study Start Date:	May 2004
Estimated Study Completion Date:	April 2006

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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
Age >= 18 years
Patient is willing to use an effective barrier method of contraception for the duration of study participation and up to three months thereafter
Patient voluntarily provides written informed consent to participate, in compliance with local law

Exclusion Criteria:

Hypersensitivity to active ingredients or any of the excipients in tipranavir or ritonavir
Required use of restricted medications
Female patients of childbearing potential who:
- Have a positive pregnancy test at baseline or
- Are breast feeding.
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.
Use of other investigational drugs, within 30 days prior to TPV/r initiation and for the duration of study participation.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144287

Show 53 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

B.I. Pharma GmbH & Co. KG

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	1182.68
Study First Received:	September 2, 2005
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00144287
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Ritonavir
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes
Tipranavir

Additional relevant MeSH terms:

Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on January 16, 2009