HIV Clinical Trial - The Rilpivirine Cerebrospinal-fluid (CSF) Study

Status Completed

Clinical Trial 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.

Clinical Trial Description

To investigate the following parameters in HIV-infected patients switching antiretroviral therapy from TDF/FTC/nevirapine to TDF/FTC/rilpivirine for 60 days:

- CSF exposure and CSF : plasma ratio of rilpivirine

- Safety and tolerability of switching antiretroviral therapy from TDF/FTC/nevirapine to TDF/FTC/rilpivirine

- Changes in cerebral metabolites measured via 1-H MRS after switching antiretroviral therapy to TDF/FTC/rilpivirine

- Seminal fluid exposure of rilpivirine ;

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01562886
Study type	Interventional
Source	Imperial College London
Contact
Status	Completed
Phase	Phase 1
Start date	March 2012
Completion date	February 2013

View Details

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