Hepatic Insufficiency Clinical Trial
Official title:
Open Label, Study to Determine the Pharmacokinetic Interactions of Steady State Tipranavir/Ritonavir (500/200 mg) and Steady State Ribavirin and Pegylated Interferon Alfa 2a in HIV Negative, HCV Infected Subjects With Mild Hepatic Impairment and the Pharmacokinetic Properties of Tipranavir/Ritonavir in HIV Negative, HCV, HBV, Hepatitis Delta Infected Subjects or Alcoholic Cirrhosis Subjects With Moderate Hepatic Impairment
The primary objectives were:
- To determine the effects of steady state TPV co-administered with low dose RTV on
steady state PegIFN and RBV in HIV negative subjects with mild hepatic impairment
(scheme A)
- To determine the effects of steady state of pegylated interferon (PegIFN) and RBV on
steady state pharmacokinetics of TPV co-administered with low dose RTV in HIV negative
subjects with mild hepatic impairment (scheme A)
- To determine the pharmacokinetics of single dose and steady state TPV/r 500/200 mg in
subjects with moderate hepatic insufficiency (scheme B)
n/a
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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