The Rilpivirine Cerebrospinal-fluid (CSF) Study

Imperial College London

Status and phase

Completed

Phase 1

Conditions

HIV

Treatments

Drug: Rilpivirine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01562886

2011-004026-98 (EudraCT Number)

278_CSF

Details and patient eligibility

About

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.

Full 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

Enrollment

14 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

HIV-1 infected males subjects
signed informed consent
willing to switch therapy as per study protocol
no previous exposure to rilpivirine
plasma HIV RNA < 50 copies/mL at screening and on at least one other occasion over the last 3 months
currently receiving a stable antiretroviral regimen comprising of TDF/FTC with nevirapine with nevirapine dosed either 200 mg twice daily or 400 mg once daily with no antiretroviral drug switches for at least 3 months
no clinically-significant resistance documented on any prior HIV-1 genotypic resistance testing
subjects in good health upon medical history, physical exam, and laboratory testing
BMI above or equal to 18 and below 32
Male subjects who are heterosexually active must use two forms of barrier contraception (e.g., condom and diaphragm) during heterosexual intercourse, from screening through completion of the study.
Have local screening laboratory results (haematology and chemistry that fall within the normal range of the central laboratory's reference ranges unless the results have been determined by the Investigator to have no clinical significance
No contraindications to having a lumbar puncture examination found on MRI of the brain