The Rilpivirine Cerebrospinal-fluid (CSF) Study
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ClinicalTrials.gov Identifier: NCT01562886 |
Recruitment Status :
Completed
First Posted : March 26, 2012
Results First Posted : June 19, 2014
Last Update Posted : June 19, 2014
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Sponsor:
Imperial College London
Collaborator:
Janssen-Cilag Ltd.
Information provided by (Responsible Party):
Imperial College London
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Study Type | Interventional |
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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 |
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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 | |
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TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily | |
Overall Number of Baseline Participants | 13 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 13 participants | |
43.8 (9.5) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 13 participants | |
Female |
0 0.0%
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Male |
13 100.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 13 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
3 23.1%
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White |
10 76.9%
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More than one race |
0 0.0%
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Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United Kingdom | Number Analyzed | 13 participants |
13 | ||
Rilpivirine CSF concentration
Geometric Mean (Full Range) Unit of measure: ng/mL |
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Number Analyzed | 13 participants | |
0.8
(0.54 to 1.57)
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 |