The Neurocognitive Sub-study of Encore1

Kirby Institute

Status and phase: Completed; Phase 3

Conditions: HIV

Treatments: Drug: Efavirenz

Study type: Interventional

Funder types: Other

Identifiers

NCT01516060

Encore1-NC

Details and patient eligibility

About

The purpose is to investigate whether HIV and HIV medication can affect certain areas of brain function. This study will look at possible changes in brain function including memory, concentration and thought processes to see if there are any differences between the two doses of efavirenz used in the Encore1 study and also the level of efavirenz in the blood

Enrollment: 71 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 brain disease
• Recent (<6months ) head injury
• Current major depression or psychosis
• Current alcohol abuse
• Intended use of recreational drugs during study period
• Uncontrolled medical conditions deemed to potentially interfere with cognitive function (e.g. uncontrolled diabetes, pyrexial illness, uraemia etc)

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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71 participants in 2 patient groups

Reduced dose Efavirenz arm

Experimental group

Description:

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).

Treatment:

Drug: Efavirenz

Drug: Efavirenz

Normal Efavirenz dose arm

Active Comparator group

Description:

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

Treatment:

Drug: Efavirenz

Drug: Efavirenz