The Rilpivirine Cerebrospinal-fluid (CSF) Study

This study has been completed.

Sponsor:

Collaborator:

Janssen-Cilag Ltd.

Information provided by (Responsible Party):

Imperial College London

ClinicalTrials.gov Identifier:

NCT01562886

First received: March 22, 2012

Last updated: May 19, 2014

Last verified: May 2014

History of Changes

Results First Received: May 19, 2014

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	HIV
Intervention:	Drug: Rilpivirine

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Rilpivirine and Truvada	TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily

Participant Flow: Overall Study

	Rilpivirine and Truvada
STARTED	14
COMPLETED	13
NOT COMPLETED	1

Baseline Characteristics

Hide Baseline Characteristics

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Rilpivirine and Truvada	TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily

Baseline Measures

	Rilpivirine and Truvada
Overall Participants Analyzed [Units: Participants]	13

Age [Units: Years] Mean (Standard Deviation)	43.8 (9.5)

Gender [Units: Participants]
Female	0
Male	13

Race (NIH/OMB) [Units: Participants]
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	3
White	10
More than one race	0
Unknown or Not Reported	0

Region of Enrollment [Units: Participants]
United Kingdom	13

Rilpivirine CSF concentration [Units: ng/mL] Geometric Mean (Full Range)	0.8 (0.54 to 1.57)

Outcome Measures

Show All Outcome Measures

1. Primary:

CSF:Plasma Ratio of Rilpivirine Levels [ Time Frame: Day 60 ]

Show Outcome Measure 1

2. Secondary:

Number of Subjects With HIV Viral Load Above 50 Copies Per mL [ Time Frame: Day 3,14, 28, 60, 80-100 ]

Show Outcome Measure 2

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

Limitations and Caveats

Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

More Information

Hide 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
e-mail: b.mora-peris@imperial.ac.uk

Responsible Party:	Imperial College London
ClinicalTrials.gov Identifier:	NCT01562886 History of Changes
Other Study ID Numbers:	278_CSF 2011-004026-98 ( EudraCT Number )
Study First Received:	March 22, 2012
Results First Received:	May 19, 2014
Last Updated:	May 19, 2014

To Top