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Trial record 1 of 1 for:    NCT01894776
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A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc (RIFAMARA)

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ClinicalTrials.gov Identifier: NCT01894776
Recruitment Status : Completed
First Posted : July 10, 2013
Results First Posted : March 10, 2020
Last Update Posted : March 10, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Tracking Information
First Submitted Date  ICMJE June 19, 2013
First Posted Date  ICMJE July 10, 2013
Results First Submitted Date  ICMJE December 20, 2019
Results First Posted Date  ICMJE March 10, 2020
Last Update Posted Date March 10, 2020
Study Start Date  ICMJE June 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2020)
  • Pharmacokinetics of Maraviroc and Rifabutin AUC 0-12/24 [ Time Frame: Maraviroc: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 hour. Rifabutin: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hour.. ]
    Maraviroc pharmacokinetics: Maraviroc only AUC (h*μg/L), Maraviroc + Rifabutin AUC (h*μg/L), Rifabutin AUC (h*μg/L), 25-O-desacetyl rifabutin AUC (h*μg/L).
  • Maraviroc and Rifabutin C12/C24/Cmax PK Concentrations in Plasma. [ Time Frame: Maraviroc: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 hour. Rifabutin: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hour.. ]
    Maraviroc + Rifabutin pharmacokinetics: Maraviroc only Cmax (μg/L), Maraviroc only C12 (μg/L), Maraviroc + Rifabutin Cmax (μg/L), Maraviroc + Rifabutin C12 (μg/L), Rifabutin Cmax (μg/L), Rifabutin C24 (μg/L), 25-O-desacetyl rifabutin Cmax (μg/L), 25-O-desacetyl rifabutin C24 (μg/L).
Original Primary Outcome Measures  ICMJE
 (submitted: July 3, 2013)
pharmacokinetics [ Time Frame: 15 days ]
Maraviroc pharmacokinetics AUC, Cmax and C12 with and without rifabutin Rifabutin and 25-O-desacetyl-rifabutin AUC, Cmax and C24
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2013)
Safety/Tolerability of the Treatments [ Time Frame: 30 days ]
description and frequency of adverse events for all participants during the study.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc
Official Title  ICMJE A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • HIV Infection
  • HIV-1 Infection
  • Mycobacterium Avium Complex (MAC)
Intervention  ICMJE
  • Drug: Rifabutin
    Substance: Rifabutin Daily dose: oral, 300 mg once daily (8:00 am) for 10 days
    Other Name: Mycobutin, RFB
  • Drug: Maraviroc
    Substance maraviroc daily dose 300 mg twice daily (8:00 am and 8:00 pm) for 15 days
    Other Name: Celsentri, MVC
Study Arms  ICMJE Experimental: Maraviroc

Two period pharmacokinetic drug-drug interaction Period one -Maraviroc alone; Period two -Maraviroc and Rifabutin

Substance: Maraviroc (Celsentri, MVC) tablets, 300 mg; dose: oral, 300 mg (1 tablet) twice daily

Substance: Rifabutin (mycobutin, RFB) capsules, 150 mg; dose: oral, 300 mg (2 capsules) once daily

Interventions:
  • Drug: Rifabutin
  • Drug: Maraviroc
Publications * Ghannad M, Dennehy M, la Porte C, Seguin I, Tardiff D, Mallick R, Sabri E, Zhang G, Kanji S, Cameron DW. A drug interaction study investigating the effect of Rifabutin on the pharmacokinetics of Maraviroc in healthy subjects. PLoS One. 2019 Oct 24;14(10):e0223969. doi: 10.1371/journal.pone.0223969. eCollection 2019.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2015)
15
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2013)
14
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Able and willing to sign informed consent prior to any study-related activities.
  • Male or female participants between 18 and 65 years of age inclusive.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • Healthy, i.e. not suffering from an acute or chronic illness and not using medications.
  • Acceptable medical history, physical examination, and 12-lead ECG at screening.
  • Acceptable laboratory values that indicate adequate baseline organ function at screening visit.
  • Willing to stop using any herbal or natural health products for 2 weeks prior to and during the study including: Grapefruit, grapefruit juice, St. John's Wort.
  • Willingness to abstain from alcohol use for 3 days prior to and during the study.
  • Participant must practice a reliable method of birth control while they are participating in the study; for instance an intrauterine device (IUD), condom with spermicidal gel or foam, diaphragm with spermicidal gel or foam, vasectomy, tubal ligation, hysterectomy or abstinence or female must be post menopausal for at least one year.

Exclusion Criteria:

  • Have serological evidence of exposure to HIV
  • Female patients of childbearing potential who has a positive urine pregnancy test at screening
  • Participants not willing to use a reliable method of barrier contraception during the study.
  • Is breastfeeding.
  • Inability to adhere to protocol.
  • Use of any medications (2 weeks prior to or during the study) other than occasional use of acetaminophen.
  • Participants taking oral contraceptive medications.
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • Patients may be excluded from the study for other reasons, at the investigator's discretion.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01894776
Other Study ID Numbers  ICMJE 2013 0080-01H
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ottawa Hospital Research Institute
Study Sponsor  ICMJE Ottawa Hospital Research Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Donald W Cameron, MD The Ottawa Hospital, Ottawa Hospital Research Institute, University of Ottawa
PRS Account Ottawa Hospital Research Institute
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP