A multicenter, randomized, open label, clinical trial to evaluate three doses of tipranavir boosted with ritonavir (500 mg/200 mg qd, 250 mg/100 mg bid and 500 mg/100 mg bid) by assessing the steady-state pharmacokinetics and short-term efficacy and safety in HIV-1 positive treatment naïve patients

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: The patients for this study are to be HIV-1 infected antiretroviral treatment-naïve men and women, from 18 to 65 years of age.
Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG
Enrollment: 84
Status: Active, not recruiting
Last Updated: 13 years ago

No summary available.

Registry

who.int

Start Date

July 6, 2007

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•3\.3\.1Inclusion criteria
•Patients meeting the following criteria will be eligible for participation in this study:
•Signed informed consent in accordance with GCP and local regulatory requirements prior to trial participation.
•HIV\-1 infected men and non\-pregnant women who are treatment naïve, with positive serology (EIA) confirmed by Western blot.
•Age \> 18 and \< 65 years.
•CD4 \> 200 cells/mm3
•Viral load (HIV\-1 mRNA viral load) \> 5,000 copies/mL.
•Ability to swallow multiple large capsules without difficulty.
•Acceptable laboratory values that indicate adequate baseline organ function at screening visit.
•Laboratory values are considered to be acceptable if the severity of any parameter is \= Grade 2, based on the DAIDS/ACTG Grading Scale (see Appendix 10\.2\).

•Exclusion criteria
•Patients with any of the following criteria are excluded from participation in this trial:
•Female patients of reproductive potential who:
•oHave positive serum pregnancy test.
•oHave not been using a barrier method of contraception for at least 3 months prior to participation in the study.
•oAre not willing to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and 60 days after completion/termination of the trial.
•oAre breast\-feeding.
•Suspected or documented seroconversion within last 6 months
•Participation in another trial with an investigational medicine within 2 months prior to Day 0 of this study.
•Use of any pharmacological contraceptive (including oral, patch or injectable contraceptives) within 1 month prior to Day 0 and for the duration of the study.