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A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc

NCT01894776 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-03-10

Study results available
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Summary

Healthy volunteers are being recruited for this pharmacokinetics study. The objective is to characterize the pharmacokinetic properties of maraviroc alone and when administered with rifabutin and to assess rifabutin and 25-O-desacetyl-rifabutin pharmacokinetics compared to the literature.

Conditions

  • HIV Infection
  • HIV-1 Infection
  • Mycobacterium Avium Complex (MAC)

Interventions

DRUG

Rifabutin

Substance: Rifabutin Daily dose: oral, 300 mg once daily (8:00 am) for 10 days

DRUG

Maraviroc

Substance maraviroc daily dose 300 mg twice daily (8:00 am and 8:00 pm) for 15 days

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Donald W Cameron, MD · The Ottawa Hospital, Ottawa Hospital Research Institute, University of Ottawa

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2013-12-31
Completion
2015-02-28

Countries

  • Canada

Study Locations

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Entities

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 NCT01894776 on ClinicalTrials.gov