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

Boehringer Ingelheim

Status

Conditions: HIV Infections

Treatments: Drug: Tipranavir

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT00933205

1182.16

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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