Pharmacokinetic (PK) Study of Single-dose Rosuvastatin and Tipranavir/Ritonavir in Healthy Subjects
Status:
Completed
Trial end date:
2008-05-01
Target enrollment:
Participant gender:
Summary
Tipranavir (TPV) plus ritonavir (RTV) is indicated for use as part of an antiretroviral
treatment regimen for resistant HIV-1 infection in adult patients. Since significant
cholesterol and triglyceride elevations are commonly reported during TPV/RTV treatment,
effective treatment strategies are critical to prevent long-term cardiovascular events.
Rosuvastatin, a potent 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitor, is
unlikely to interact with TPV/RTV since it is not extensively metabolized, however, a formal
drug interaction study is needed before this combination can be recommended. This study will
examine the pharmacokinetic interactions between tipranavir/ritonavir (TPV/RTV [TPV/r] 500
mg/200 mg twice daily [B.I.D]) and single dose rosuvastatin when the two are co-administered
to healthy adult volunteers. The investigators hypothesize that if tipranavir 500 mg is
co-administered with low-dose ritonavir 200 mg and rosuvastatin (10 mg) no significant
clinical interaction will occur.