CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
darunavir, ritonavir, rosuvastatin +1 moredrug
Likely dose
darunavir, ritonavir, rosuvastatin 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00885495
NCT00885495Phase 2Completed
CompareCT.gov

The Effects of Darunavir Plus Ritonavir on the Pharmacokinetics and Pharmacodynamics of Rosuvastatin

University of Cincinnati·interventional·Posted Apr 22, 2009·Updated Feb 11, 2022

In Brief

A Phase 2 clinical trial evaluating darunavir, ritonavir, rosuvastatin and rosuvastatin, darunavir, ritonavir for HIV Infections. Completed, enrolled 17 participants across 1 site.

Detailed Summary

This is a phase I, open-label, controlled drug interaction study to determine the effects of darunavir plus ritonavir on the pharmacokinetics of the hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, rosuvastatin, in HIV-1-seronegative subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 22, 2009
Enrollment StartJan 1, 2009
Primary CompletionApr 1, 2010
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.2 years ago

Interventions

darunavir, ritonavir, rosuvastatindrug

darunavir 600 mg twice daily for 7 days ritonavir 100 mg twice daily for 7 days rosuvastatin 10 mg once daily for 7 days Combination of all three drugs for 7 days

rosuvastatin, darunavir, ritonavirdrug

rosuvastatin 10 mg daily for 7 days; darunavir 600 mg twice daily for 7 days with ritonavir 100 mg twice daily for 7 days; Combination of all three for 7 days