The Efavirenz (EFV) central nervous system exposure sub-study

The CNS sub-study of a randomised, double-blind, placebo-controlled, clinical trial to compare the safety and efficacy of reduced dose efavirenz (EFV) with standard dose EFV plus 2N(t)RTI in antiretroviral-naive HIV-infected individuals over 96 weeks

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612001194853

Acronym

The CNS sub-study for Encore1

Enrollment

Registered

2012-11-13

Start date

2011-09-16

Completion date

Unknown

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Persistent HIV replication 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 sub-therapeutic concentrations of antiretroviral drugs in the CNS.

Interventions

Tenofovir (TDF) (300mg qd (once daily))/emtricitabine (FTC) (200mg qd) + efavirenz(EFV )(600mg qd; 3 x 200mg qd) all oral tablets

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

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 Bacterial or viral meningitis in the past 12 weeks Head injury requiring medical assessment in the past 12 weeks

Outcome results