The Efavirenz (EFV) Central Nervous System Exposure Sub-study of Encore1 (ENCORE1-CNS)

Kirby Institute

Status and phase

Completed

Phase 3

Conditions

HIV Infection

Treatments

Drug: Efavirenz

Study type

Interventional

Funder types

Other

Identifiers

NCT01451333

NCHECR-ENCORE1-CNS

Details and patient eligibility

About

Persistent HIV infection in the central nervous system (CNS) compartment may put subjects at risk of developing HIV-related brain disease. Important factors associated with the development of HIV-related brain disease include therapeutic concentrations of antiretroviral drugs in the CNS. Conflicting evidence regarding the CNS exposure of the antiretroviral drug used for the encore1 study, efavirenz (EFV) have been described in related studies. There were recent study of two small series assessment of EFV exposure in the cerebral spinal fluid (CSF); one group reported small detectable EFV concentrations, while another observed undetectable EFV exposure in the CSF. Also, in a larger reported series comprising of 80 subjects on EFV-containing antiretroviral therapy, a CSF to plasma concentration suggested that there is limited movement of EFV out of the CSF. In HIV-1 infected subjects at steady state, EFV plasma level parameters are dose proportional following 200mg, 400mg, and 600mg daily doses. The CNS exposure of EFV at different daily dosing has not been described.

Enrollment

32 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All subjects entering into the main study protocol at participating centres will be eligible to enter this sub-study.

Exclusion criteria

Existing neurological disease which in the opinion of the investigator would be a contra-indication to lumbar puncture examination
CNS opportunistic infections in the past 12 weeks of randomisation
Bacterial or viral meningitis in the past 12 weeks of randomisation
Head injury requiring medical assessment in the past 12 weeks of randomisation