Overview

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

Status:
Completed
Trial end date:
2006-04-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Ritonavir
Tipranavir
Criteria
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.