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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01894776
First received: June 19, 2013
Last updated: March 11, 2014
Last verified: March 2014

June 19, 2013
March 11, 2014
June 2013
December 2013   (final data collection date for primary outcome measure)
pharmacokinetics [ Time Frame: 15 days ] [ Designated as safety issue: No ]
Maraviroc pharmacokinetics AUC, Cmax and C12 with and without rifabutin Rifabutin and 25-O-desacetyl-rifabutin AUC, Cmax and C24
Same as current
Complete list of historical versions of study NCT01894776 on ClinicalTrials.gov Archive Site
safety/tolerability of the treatments [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
description and frequency of adverse events for all participants during the study.
Same as current
Not Provided
Not Provided
 
A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc
A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc

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.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
  • HIV Infection
  • HIV-1 Infection
  • Mycobacterium Avium Complex (MAC)
  • 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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
14
October 2014
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01894776
2013 0080-01H
Yes
Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
Pfizer
Principal Investigator: Donald W Cameron, MD The Ottawa Hospital, Ottawa Hospital Research Institute, University of Ottawa
Ottawa Hospital Research Institute
March 2014

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