Status and phase
Conditions
Treatments
About
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.
Full 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 efficacy assessment will be performed by evaluating:
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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:
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:
(*) 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.
Primary purpose
Allocation
Interventional model
Masking
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal