The Rilpivirine Cerebrospinal-fluid (CSF) Study

• ClinicalTrials.gov Identifier: NCT01562886
• Recruitment Status: Completed
• First Posted: March 26, 2012
• Results First Posted: June 19, 2014
• Last Update Posted: June 19, 2014
• Sponsor: Imperial College London
• Collaborator: Janssen-Cilag Ltd.
• Information provided by (Responsible Party): Imperial College London

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: HIV
• Intervention: Drug: Rilpivirine
• Enrollment: 14

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Rilpivirine and Truvada
Arm/Group Description	TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily
Period Title: Overall Study
Started	14
Completed	13
Not Completed	1

Baseline Characteristics

Arm/Group Title		Rilpivirine and Truvada
Arm/Group Description		TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily
Overall Number of Baseline Participants		13
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	13 participants
		43.8 (9.5)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	13 participants
	Female	0 0.0%
	Male	13 100.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	13 participants
	American Indian or Alaska Native	0 0.0%
	Asian	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	3 23.1%
	White	10 76.9%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United Kingdom	Number Analyzed	13 participants
		13
Rilpivirine CSF concentration; Geometric Mean (Full Range); Unit of measure: ng/mL
	Number Analyzed	13 participants
		0.8; (0.54 to 1.57)

Outcome Measures

1. Primary Outcome

Title	CSF:Plasma Ratio of Rilpivirine Levels
Description	The levels of rilpivirine will be measured in the cerebral spinal fluid and plasma after 60 days of exposure
Time Frame	Day 60

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rilpivirine and Truvada
Arm/Group Description:	TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily Rilpivirine: Rilpivirine 25mg
Overall Number of Participants Analyzed	13
Geometric Mean (95% Confidence Interval); Unit of Measure: ratio expressed as a percentage
	1.4; (1.2 to 1.6)

2. Secondary Outcome

Title	Number of Subjects With HIV Viral Load Above 50 Copies Per mL
Description	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)
Time Frame	Day 3,14, 28, 60, 80-100

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rilpivirine and Truvada
Arm/Group Description:	TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily Rilpivirine: Rilpivirine 25mg
Overall Number of Participants Analyzed	13
Measure Type: Number; Unit of Measure: participants
	2

Adverse Events

Time Frame	Duration of the study
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Rilpivirine and Truvada
Arm/Group Description	TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily Rilpivirine: Rilpivirine 26mg
All-Cause Mortality
	Rilpivirine and Truvada
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Rilpivirine and Truvada
	Affected / at Risk (%)	# Events
Total	0/13 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Rilpivirine and Truvada
	Affected / at Risk (%)	# Events
Total	3/13 (23.08%)
Nervous system disorders
Insomnia †	3/13 (23.08%)	13
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr Borja Mora Peris
• Organization: Imperial College London
• Phone: 020 3312 6789
• EMail: b.mora-peris@imperial.ac.uk

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT01562886
• Other Study ID Numbers: 278_CSF; 2011-004026-98 ( EudraCT Number )
• First Submitted: March 22, 2012
• First Posted: March 26, 2012
• Results First Submitted: May 19, 2014
• Results First Posted: June 19, 2014
• Last Update Posted: June 19, 2014