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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Reduced dose Efavirenz arm

Patient's on main study that was randomised to receive TDF (300mg qd)/FTC (200mg qd) + EFV (400mg qd; 2 x 200mg + 1 x 200mg placebo qd).

Group Type EXPERIMENTAL

Efavirenz

Intervention Type DRUG

400mg qd; 2 x 200mg

Normal Efavirenz dose arm

Patient's on main study randomised to receive tenofovir (TDF) (300mg qd)/emtricitabine (FTC) (200mg qd) + EFV (600mg qd; 3 x 200mg qd)

Group Type ACTIVE_COMPARATOR

Efavirenz

Intervention Type DRUG

600mg qd; 3 x 200mg qd

Interventions

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Efavirenz

600mg qd; 3 x 200mg qd

Intervention Type DRUG

Efavirenz

400mg qd; 2 x 200mg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No