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:	Endpoint Classification: Pharmacokinetics Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	HIV
Intervention:	Drug: Rilpivirine

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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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.
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Reporting Groups

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

Baseline Measures

	Rilpivirine and Truvada
Number of Participants [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

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1. Primary:

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

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2. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
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More Information

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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
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

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