ClinicalTrials.gov
ClinicalTrials.gov Menu

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

  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

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

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


  Other Adverse Events


  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

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 )
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