The rilpivirine CSF study

• Research type

  Research Study

• Full title

  A phase I pharmacokinetic study to assess the cerebrospinal-fluid (CSF) exposure of rilpivirine in HIV-infected subjects switching from TDF/FTC/nevirapine to TDF/FTC/rilpivirine. The rilpivirine CSF study

• IRAS ID

  82816

• Contact name

  Alan Winston

• Sponsor organisation

  Imperial College London and Imperial College Healthcare NHS Trust

• Eudract number

  2011-004026-98

• ISRCTN Number

  Unknown

• Research 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.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  11/LO/1536

• Date of REC Opinion

  23 Nov 2011

• REC opinion

  Favourable Opinion