Trial Outcomes & Findings for The Rilpivirine Cerebrospinal-fluid (CSF) Study (NCT NCT01562886)

NCT ID: NCT01562886

Last Updated: 2014-06-19

Results Overview

The levels of rilpivirine will be measured in the cerebral spinal fluid and plasma after 60 days of exposure

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 14 participants
• Primary outcome timeframe: Day 60
• Results posted on: 2014-06-19

Participant Flow

Participant milestones

Measure	Rilpivirine and Truvada TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily
Overall Study STARTED	14
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Rilpivirine Cerebrospinal-fluid (CSF) Study

Baseline characteristics by cohort

Measure	Rilpivirine and Truvada n=13 Participants TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily
Age, Continuous	43.8 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	13 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	10 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	13 participants n=5 Participants
Rilpivirine CSF concentration	0.8 ng/mL n=5 Participants

PRIMARY outcome

Timeframe: Day 60

The levels of rilpivirine will be measured in the cerebral spinal fluid and plasma after 60 days of exposure

Outcome measures

Measure	Rilpivirine and Truvada n=13 Participants TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily Rilpivirine: Rilpivirine 25mg
CSF:Plasma Ratio of Rilpivirine Levels	1.4 ratio expressed as a percentage Interval 1.2 to 1.6

SECONDARY outcome

Timeframe: Day 3,14, 28, 60, 80-100

Plasma viral load will be measured at all study visits to assess if viral load is above the lower limit of detection (50 copies mL)

Outcome measures

Measure	Rilpivirine and Truvada n=13 Participants TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily Rilpivirine: Rilpivirine 25mg
Number of Subjects With HIV Viral Load Above 50 Copies Per mL	2 participants

Adverse Events

Rilpivirine and Truvada

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Rilpivirine and Truvada n=13 participants at risk TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily Rilpivirine: Rilpivirine 26mg
Nervous system disorders Insomnia	23.1% 3/13 • Number of events 13 • Duration of the study

Additional Information

Dr Borja Mora Peris

Imperial College London

Phone: 020 3312 6789

Email: b.mora-peris@imperial.ac.uk

Results disclosure agreements

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