Trial Outcomes & Findings for A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc (NCT NCT01894776)
NCT ID: NCT01894776
Last Updated: 2020-03-10
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
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..
Results posted on
2020-03-10
Participant Flow
The Clinical Investigation Unit (CIU) at the OHRI has a database of healthy volunteers interested in participating in clinical studies who were contacted and recruited by phone or email. The first patient was recruited on 06 Sept 2013 and the last follow-up visit was on 23 Dec 2013.
Participant milestones
| Measure |
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
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
|
|---|---|
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Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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
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
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|---|---|
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Overall Study
Withdrawal by Subject
|
1
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Baseline Characteristics
15 patients underwent baseline measurements and allocated to intervention. However, only 14 were analyzed due to 1 participant withdrawing from the study due to Nausea.
Baseline characteristics by cohort
| Measure |
Maraviroc
n=14 Participants
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
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
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=14 Participants • 15 patients underwent baseline measurements and allocated to intervention. However, only 14 were analyzed due to 1 participant withdrawing from the study due to Nausea.
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|
Age, Categorical
Between 18 and 65 years
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14 Participants
n=14 Participants • 15 patients underwent baseline measurements and allocated to intervention. However, only 14 were analyzed due to 1 participant withdrawing from the study due to Nausea.
|
|
Age, Categorical
>=65 years
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0 Participants
n=14 Participants • 15 patients underwent baseline measurements and allocated to intervention. However, only 14 were analyzed due to 1 participant withdrawing from the study due to Nausea.
|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 13 • n=14 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=14 Participants • 15 patients underwent baseline measurements and allocated to intervention. However, only 14 were analyzed due to 1 participant withdrawing from the study due to Nausea.
|
|
Sex: Female, Male
Male
|
7 Participants
n=14 Participants • 15 patients underwent baseline measurements and allocated to intervention. However, only 14 were analyzed due to 1 participant withdrawing from the study due to Nausea.
|
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Region of Enrollment
Canada
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14 participants
n=14 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Maraviroc
n=14 Participants
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
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
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|---|---|
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Pharmacokinetics of Maraviroc and Rifabutin AUC 0-12/24
Maraviroc only AUC (h*μg/L)
|
1026.2 h*μg/L
Interval 923.58 to 1128.82
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|
Pharmacokinetics of Maraviroc and Rifabutin AUC 0-12/24
Maraviroc + Rifabutin AUC (h*μg/L)
|
847.0 h*μg/L
Interval 762.3 to 931.7
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|
Pharmacokinetics of Maraviroc and Rifabutin AUC 0-12/24
Rifabutin AUC (h*μg/L)
|
4221.9 h*μg/L
Interval 3799.71 to 4644.09
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|
Pharmacokinetics of Maraviroc and Rifabutin AUC 0-12/24
25-O-desacetyl rifabutin AUC (h*μg/L)
|
331.9 h*μg/L
Interval 298.71 to 365.09
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PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Maraviroc
n=14 Participants
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
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
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|---|---|
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Maraviroc and Rifabutin C12/C24/Cmax PK Concentrations in Plasma.
Maraviroc only Cmax (μg/L)
|
304.6 μg/L
Interval 274.14 to 335.06
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Maraviroc and Rifabutin C12/C24/Cmax PK Concentrations in Plasma.
Maraviroc only C12 (μg/L)
|
23.3 μg/L
Interval 20.97 to 25.63
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|
Maraviroc and Rifabutin C12/C24/Cmax PK Concentrations in Plasma.
Maraviroc + Rifabutin Cmax (μg/L)
|
239.8 μg/L
Interval 215.82 to 263.78
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|
Maraviroc and Rifabutin C12/C24/Cmax PK Concentrations in Plasma.
Maraviroc + Rifabutin C12 (μg/L)
|
16.3 μg/L
Interval 14.67 to 17.93
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|
Maraviroc and Rifabutin C12/C24/Cmax PK Concentrations in Plasma.
Rifabutin Cmax (μg/L)
|
542.2 μg/L
Interval 487.98 to 596.42
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|
Maraviroc and Rifabutin C12/C24/Cmax PK Concentrations in Plasma.
Rifabutin C24 (μg/L)
|
71.2 μg/L
Interval 64.08 to 78.32
|
|
Maraviroc and Rifabutin C12/C24/Cmax PK Concentrations in Plasma.
25-O-desacetyl rifabutin Cmax (μg/L)
|
42.3 μg/L
Interval 38.07 to 46.53
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|
Maraviroc and Rifabutin C12/C24/Cmax PK Concentrations in Plasma.
25-O-desacetyl rifabutin C24 (μg/L)
|
5.5 μg/L
Interval 4.95 to 6.05
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SECONDARY outcome
Timeframe: 30 daysdescription and frequency of adverse events for all participants during the study.
Outcome measures
| Measure |
Maraviroc
n=14 Participants
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
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
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|---|---|
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Safety/Tolerability of the Treatments
Maraviroc · Number of Participants with Adverse Events
|
6 Participants
|
|
Safety/Tolerability of the Treatments
Maraviroc · Number of Participants without Adverse Events
|
8 Participants
|
|
Safety/Tolerability of the Treatments
Maraviroc + Rifabutin · Number of Participants with Adverse Events
|
7 Participants
|
|
Safety/Tolerability of the Treatments
Maraviroc + Rifabutin · Number of Participants without Adverse Events
|
7 Participants
|
Adverse Events
Maraviroc
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Maraviroc
n=14 participants at risk
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
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
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|---|---|
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Musculoskeletal and connective tissue disorders
Joint pain
|
14.3%
2/14 • 30 days.
|
|
General disorders
Fever
|
14.3%
2/14 • 30 days.
|
|
Nervous system disorders
Headache
|
42.9%
6/14 • 30 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
7.1%
1/14 • 30 days.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place