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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01894776
Recruitment Status : Completed
First Posted : July 10, 2013
Last Update Posted : March 3, 2015
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.

Condition or disease Intervention/treatment Phase
HIV Infection HIV-1 Infection Mycobacterium Avium Complex (MAC) Drug: Rifabutin Drug: Maraviroc Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc
Study Start Date : June 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
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

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. safety/tolerability of the treatments [ Time Frame: 30 days ]
    description and frequency of adverse events for all participants during the study.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01894776

Canada, Ontario
The Ottawa Hospital -General Campus
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Principal Investigator: Donald W Cameron, MD The Ottawa Hospital, Ottawa Hospital Research Institute, University of Ottawa

Responsible Party: Ottawa Hospital Research Institute Identifier: NCT01894776     History of Changes
Other Study ID Numbers: 2013 0080-01H
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: March 2015

Keywords provided by Ottawa Hospital Research Institute:
healthy volunteers

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Nontuberculous
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antibiotics, Antitubercular
Antitubercular Agents