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Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz

NCT01695954 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-08-11

Study results available
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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.

Conditions

Interventions

DRUG

Pitavastatin

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

DRUG

Darunavir

Darunavir 400 mg tablets x 2 taken daily in Arm B

DRUG

Ritonavir

Ritonavir 100 mg tablets taken daily in Arm B

DRUG

Efavirenz

Efavirenz 600 mg tablets taken at bedtime in Arm A

Sponsors & Collaborators

  • New York City Health and Hospitals Corporation

    collaborator OTHER

  • Kowa Pharmaceuticals America, Inc.

    collaborator INDUSTRY

  • University at Buffalo

    collaborator OTHER

  • NYU Langone Health

    lead OTHER

Principal Investigators

  • Judith Aberg, M.D. · NYU School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01695954 on ClinicalTrials.gov