CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 34 enrolled
Drug / intervention
Pitavastatin +3 moredrug
Likely dose
Pitavastatin 2 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/NCT01695954
NCT01695954Phase 1Completed
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The Effect of Efavirenz and Ritonavir-boosted Darunavir on the Pharmacokinetics of the HMG CoA Reductase Inhibitor Pitavastatin

NYU Langone Health·interventional·Posted Sep 28, 2012·Updated Aug 11, 2020

In Brief

A Phase 1 clinical trial evaluating Pitavastatin, Darunavir, and 2 other interventions for Hyperlipidemia and HIV. Completed, enrolled 34 participants across 1 site.

Detailed Summary

The main goal of this study is to determine how taking efavirenz affects the levels of pitavastatin in the bloodstream when both drugs are taken together and to see how darunavir with ritonavir affects the levels of pitavastatin in the bloodstream. Secondary goals are to see how taking pitavastatin affects the levels in the blood of efavirenz when both drugs are taken together and to see how taking pitavastatin affects the levels in the blood of darunavir.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperlipidemia, HIV
CountriesUnited States
CollaboratorsNew York City Health and Hospitals Corporation, Kowa Pharmaceuticals America, Inc., University at Buffalo

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 28, 2012
Enrollment StartMay 1, 2012
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.8 years ago

Interventions

Pitavastatindrug

Pitavastatin 2 mg tablets taken at bedtime in Arm A and in the morning in Arm B.

Darunavirdrug

Darunavir 400 mg tablets x 2 taken daily in Arm B

Ritonavirdrug

Ritonavir 100 mg tablets taken daily in Arm B

Efavirenzdrug

Efavirenz 600 mg tablets taken at bedtime in Arm A