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

HIV Infection Clinical Trial

— RIFAMARA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894776
• Other study ID #: 2013 0080-01H
• Status: Completed
• Phase: Phase 1
• Start date: June 2013
• Est. completion date: February 2015

Study information

• Verified date: February 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infection
• HIV-1 Infection
• Infection
• Mycobacterium Avium Complex (MAC)
• Mycobacterium avium-intracellulare Infection

Intervention

Drug:
• Rifabutin
Substance: Rifabutin Daily dose: oral, 300 mg once daily (8:00 am) for 10 days
• Maraviroc
Substance maraviroc daily dose 300 mg twice daily (8:00 am and 8:00 pm) for 15 days

Locations

Country	Name	City	State
Canada	The Ottawa Hospital -General Campus	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Pfizer

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: 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..
Primary	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).	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	Safety/Tolerability of the Treatments	description and frequency of adverse events for all participants during the study.	30 days