The Neurocognitive Sub Study of Encore1: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-naïve HIV-Infected Individuals Over 96 Weeks A Randomised, Double-blind, Placebo-controlled, Clinical Trial to Compare the Safety and Efficacy of Reduced Dose Efavirenz (EFV) With Standard Dose EFV Plus Two Nucleotide Reverse Transcriptase Inhibitors (N(t)RTI) in Antiretroviral-naïve HIV-infected Individuals Over 96 Weeks
Overview
- Phase
- Phase 3
- Intervention
- Efavirenz
- Conditions
- HIV
- Sponsor
- Kirby Institute
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- The primary endpoint is the comparison between of neurocognitive function in patients initiating sdEFV and 400EFV
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
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)
Arms & Interventions
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).
Intervention: Efavirenz
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)
Intervention: Efavirenz
Outcomes
Primary Outcomes
The primary endpoint is the comparison between of neurocognitive function in patients initiating sdEFV and 400EFV
Time Frame: 48 weeks
Secondary Outcomes
- The association between week 4 plasma EFV levels and change from baseline neurocognitive function to week 4 and 24.(Week 24)
- To assess dynamic changes in neurocognitive function over the total duration of follow-up.(96 weeks)