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The Rilpivirine Cerebrospinal-fluid (CSF) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rilpivirine and Truvada
Hide 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
Arm/Group Title Rilpivirine and Truvada
Hide Arm/Group Description TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily
Overall Number of Baseline Participants 13
Hide 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)
1.Primary Outcome
Title CSF:Plasma Ratio of Rilpivirine Levels
Hide Description The levels of rilpivirine will be measured in the cerebral spinal fluid and plasma after 60 days of exposure
Time Frame Day 60
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rilpivirine and Truvada
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rilpivirine and Truvada
Hide 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
Time Frame Duration of the study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rilpivirine and Truvada
Hide 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   --/--    
Hide Serious Adverse Events
Rilpivirine and Truvada
Affected / at Risk (%) # Events
Total   0/13 (0.00%)    
Hide 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
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Borja Mora Peris
Organization: Imperial College London
Phone: 020 3312 6789
EMail: b.mora-peris@imperial.ac.uk
Layout table for additonal information
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