Conditions: HIV
Keywords: Rilpivirine CSF pharmacokinetics
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 14
Healthy volunteers: no

Brief 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.

Detailed 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

Arms:
arm 1: TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily

Interventions: intervention 1: Rilpivirine
Intervention descriptions: intervention 1: Rilpivirine 26mg

Protocol document: