A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc
Condition: HIV Infection; HIV-1 Infection; Mycobacterium Avium Complex (MAC)
MeSH terms: Infections; Communicable Diseases; Mycobacterium avium-intracellulare Infection
Intervention: Rifabutin; Maraviroc
Intervention description: Substance: Rifabutin Daily dose: oral, 300 mg once daily (8:00 am) for 10 days; Substance maraviroc daily dose 300 mg twice daily (8:00 am and 8:00 pm) for 15 days
Intervention MeSH terms: Maraviroc; Rifabutin
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: healthy volunteers

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.
    

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.