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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01894776
• Date of registration: 19/06/2013
• Prospective Registration: No
• Primary sponsor: Ottawa Hospital Research Institute
• Public title: A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc RIFAMARA
• Scientific title: A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc
• Date of first enrolment: June 2013
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01894776
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Canada

Contacts

• Name: Donald W Cameron, MD
• Affiliation: The Ottawa Hospital, Ottawa Hospital Research Institute, University of Ottawa

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Mycobacterium Avium Complex (MAC)

HIV-1 Infection

HIV Infection

Intervention(s)

Drug: Maraviroc

Drug: Rifabutin

Primary Outcome(s)

Maraviroc and Rifabutin C12/C24/Cmax PK Concentrations in Plasma. [Time Frame: 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..]

Pharmacokinetics of Maraviroc and Rifabutin AUC 0-12/24 [Time Frame: 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 Outcome(s)

Safety/Tolerability of the Treatments [Time Frame: 30 days]

Secondary ID(s)

2013 0080-01H

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pfizer

Results

• Results available: Yes
• Date Posted: 10/03/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01894776