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The Rilpivirine Cerebrospinal-fluid (CSF) Study

NCT01562886 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2014-06-19

Study results available
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Summary

This is a phase I pharmacokinetic study of HIV positive patients stable on antiretroviral therapy who will switch treatment when enrolled from nevirapine to rilpivirine. On day 60 of the study the participants will attend clinic where they will have blood collected followed by a lumbar puncture where cerebrospinal fluid will be collected to measure drug concentration. The participants will then restart their original regime with nevirapine.

Conditions

Interventions

DRUG

Rilpivirine

Rilpivirine 26mg

Sponsors & Collaborators

  • Janssen-Cilag Ltd.

    collaborator INDUSTRY

  • Imperial College London

    lead OTHER

Principal Investigators

  • Alan Winston, MBChB MD · Imperial College London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-11-30
Completion
2013-02-28

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01562886 on ClinicalTrials.gov