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

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Rifabutin
Maraviroc
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HIV Infection focused on measuring healthy volunteers

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The Ottawa Hospital -General Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Maraviroc

Arm Description

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

Outcomes

Primary Outcome Measures

Pharmacokinetics of Maraviroc and Rifabutin AUC 0-12/24
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.
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).

Secondary Outcome Measures

Safety/Tolerability of the Treatments
description and frequency of adverse events for all participants during the study.

Full Information

First Posted
June 19, 2013
Last Updated
February 25, 2020
Sponsor
Ottawa Hospital Research Institute
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01894776
Brief Title
A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc
Acronym
RIFAMARA
Official Title
A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, HIV-1 Infection, Mycobacterium Avium Complex (MAC)
Keywords
healthy volunteers

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maraviroc
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Rifabutin
Other Intervention Name(s)
Mycobutin, RFB
Intervention Description
Substance: Rifabutin Daily dose: oral, 300 mg once daily (8:00 am) for 10 days
Intervention Type
Drug
Intervention Name(s)
Maraviroc
Other Intervention Name(s)
Celsentri, MVC
Intervention Description
Substance maraviroc daily dose 300 mg twice daily (8:00 am and 8:00 pm) for 15 days
Primary Outcome Measure Information:
Title
Pharmacokinetics of Maraviroc and Rifabutin AUC 0-12/24
Description
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).
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..
Title
Maraviroc and Rifabutin C12/C24/Cmax PK Concentrations in Plasma.
Description
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).
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..
Secondary Outcome Measure Information:
Title
Safety/Tolerability of the Treatments
Description
description and frequency of adverse events for all participants during the study.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald W Cameron, MD
Organizational Affiliation
The Ottawa Hospital, Ottawa Hospital Research Institute, University of Ottawa
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital -General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
31647836
Citation
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.
Results Reference
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A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc

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