A Phase 3 interventional study of Tipranavir/Ritonavir in HIV Infections, sponsored by Boehringer Ingelheim. Completed at 53 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-05.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
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.
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.
4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 255 is above the median of 83 across 3,312 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Boehringer Ingelheim is the lead sponsor of 2,297 studies on the registry; 56 are open to participants now.
Of its 166 completed or terminated interventional studies of FDA-regulated products, 121 (73%) have results posted.
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Exclusion Criteria:
Female patients of childbearing potential who:
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.
Drug pages: Tipranavir · Ritonavir
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
The quantity of HIV-1 RNA
The CD4 cell count
The record gives a start of May 2004, a primary completion of Apr 2006 and a completion of Apr 2006. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Tipranavir · Ritonavir