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

Phase 1

Completed

• Conditions: HIV Infection; HIV-1 Infection; Mycobacterium Avium Complex (MAC)
• Interventions: Drug: Rifabutin; Drug: Maraviroc

• Registration Number: NCT01894776
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-19
• Study First Submitted QC: 2013-07-03
• Study First Posted: 2013-07-10
• Primary Completion: 2013-12
• Study Completion: 2015-02
• Results First Submitted: 2019-12-20
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-25
• Last Update Submitted: 2020-02-25
• Results First Posted: 2020-03-10
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Maraviroc	Rifabutin	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
Maraviroc	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety/Tolerability of the Treatments	30 days	description and frequency of adverse events for all participants during the study.

Trial Locations

Locations (1)

The Ottawa Hospital -General Campus; 🇨🇦 Ottawa, Ontario, Canada