Trial Outcomes & Findings for The Maraviroc Central Nervous System (CNS) Study (NCT NCT00982878)

NCT ID: NCT00982878

Last Updated: 2019-11-04

Results Overview

To describe the CNS exposure of maraviroc in HIV-1 infected subjects receiving a stable antiretroviral regimen, including maraviroc, at steady state. It were assessed by in vivo cerebral (1)H magnetic resonance spectroscopy ((1)H-MRS). Cerebral MRS imaging (T1- and T2-weighted images) was performed on a Phillips Achieva™ 1.5 Tesla magnetic resonance (MR) scanner (Phillips NV, Best, Netherlands) and studied by an experienced neuroradiologist

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 13 participants
• Primary outcome timeframe: 15 days
• Results posted on: 2019-11-04

Participant Flow

Participant milestones

Measure	Maraviroc Maraviroc: 150mg twice daily
Overall Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Maraviroc Maraviroc: 150mg twice daily
Overall Study Physician Decision	1

Baseline Characteristics

The Maraviroc Central Nervous System (CNS) Study

Baseline characteristics by cohort

Measure	Maraviroc n=12 Participants Maraviroc: 150mg twice daily
Age, Continuous	42 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	9 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	7 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United Kingdom	12 participants n=5 Participants
Years since HIV diagnosis	11 years STANDARD_DEVIATION 4.6 • n=5 Participants
Baseline CD4 cell count	503 cells/ul STANDARD_DEVIATION 199 • n=5 Participants
BMI	28 kg/m^2 STANDARD_DEVIATION 3.5 • n=5 Participants

PRIMARY outcome

Timeframe: 15 days

To describe the CNS exposure of maraviroc in HIV-1 infected subjects receiving a stable antiretroviral regimen, including maraviroc, at steady state.

It were assessed by in vivo cerebral (1)H magnetic resonance spectroscopy ((1)H-MRS).

Cerebral MRS imaging (T1- and T2-weighted images) was performed on a Phillips Achieva™ 1.5 Tesla magnetic resonance (MR) scanner (Phillips NV, Best, Netherlands) and studied by an experienced neuroradiologist

Outcome measures

Measure	Maraviroc n=12 Participants Maraviroc: 150mg twice daily
CSF (Cerebrospinal Fluid) : Plasma Ratio of Maraviroc 1H Magnetic Resonance Spectroscopy (1H-MRS)	1.01 ratio Interval 0.57 to 1.61

SECONDARY outcome

Timeframe: 15 days

To evaluate the short term safety and tolerability of maraviroc in HIV-1 infected subjects on stable antiretroviral therapy

Outcome measures

Measure	Maraviroc n=12 Participants Maraviroc: 150mg twice daily
Number of Participants With Adverse Events	0 Participants

Adverse Events

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

Professor Alan Winston

Imperial College London

Phone: +44 (0)20 3312 1603

Email: a.winston@imperial.ac.uk

Results disclosure agreements

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