Trial Outcomes & Findings for The Maraviroc Darunavir/Ritonavir Once Daily Pharmacokinetic Study (NCT NCT01348763)

NCT ID: NCT01348763

Last Updated: 2019-10-31

Results Overview

On day 10 of the study the maximum concentractions of maraviroc will be measured . On day 20 of the study the maximum plasma concentractions maraviroc will be measured .

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 13 participants
• Primary outcome timeframe: 10 day, 20 days
• Results posted on: 2019-10-31

Participant Flow

Participant milestones

Measure	Truvada, Darunavir/r and Maraviroc Participants will be taking Truvada, Darunavir/r before entering the study. On day 1 they will add maraviroc then on day 11 they will stop the Truvada Maraviroc: Maraviroc 150 mg daily
With Tenofovir/Emtricitabine (10 Days) STARTED	13
With Tenofovir/Emtricitabine (10 Days) COMPLETED	11
With Tenofovir/Emtricitabine (10 Days) NOT COMPLETED	2
Without Tenofovir/Emtricitabine (11 Day) STARTED	11
Without Tenofovir/Emtricitabine (11 Day) COMPLETED	11
Without Tenofovir/Emtricitabine (11 Day) NOT COMPLETED	0

Reasons for withdrawal

Measure	Truvada, Darunavir/r and Maraviroc Participants will be taking Truvada, Darunavir/r before entering the study. On day 1 they will add maraviroc then on day 11 they will stop the Truvada Maraviroc: Maraviroc 150 mg daily
With Tenofovir/Emtricitabine (10 Days) Withdrawal by Subject	1
With Tenofovir/Emtricitabine (10 Days) Physician Decision	1

Baseline Characteristics

The Maraviroc Darunavir/Ritonavir Once Daily Pharmacokinetic Study

Baseline characteristics by cohort

Measure	Truvada, Darunavir/r and Maraviroc n=11 Participants Participants will be taking Truvada, Darunavir/r before entering the study. On day 1 they will add maraviroc then on day 11 they will stop the Truvada Maraviroc: Maraviroc 150 mg daily
Age, Continuous	48 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United Kingdom	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 day, 20 days

On day 10 of the study the maximum concentractions of maraviroc will be measured . On day 20 of the study the maximum plasma concentractions maraviroc will be measured .

Outcome measures

Measure	Truvada, Darunavir/r and Maraviroc n=11 Participants Participants will be taking Truvada, Darunavir/r before entering the study. On day 1 they will add maraviroc then on day 11 they will stop the Truvada Maraviroc: Maraviroc 150 mg daily
The Ratio of the Maximum Plasma Concentration of Maraviroc Between 20 and 10 Day	0.99 ratio Interval 0.79 to 1.25

SECONDARY outcome

Timeframe: 35 days

Population: No data reported

Haematology and biochemistry laboratory tests such as full blood count, elelectrolytes and lipids will be measured to assess for changes.

Outcome measures

Measure	Truvada, Darunavir/r and Maraviroc n=11 Participants Participants will be taking Truvada, Darunavir/r before entering the study. On day 1 they will add maraviroc then on day 11 they will stop the Truvada Maraviroc: Maraviroc 150 mg daily
Number of Participants With Changes in Haematology and Biochemistry Laboratory Tests	0 Participants

Adverse Events

Truvada, Darunavir/r and Maraviroc

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alan Winston

Imperial College London

Phone: +442033121603

Email: a.winston@imperial.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place