The Neurocognitive Sub-study of Encore1

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516060
• Other study ID #: Encore1-NC
• Status: Completed
• Phase: Phase 3
• First received: January 19, 2012
• Last updated: September 18, 2013
• Start date: January 2012
• Est. completion date: March 2013

Study information

• Verified date: September 2013
• Source: Kirby Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeUnited Kingdom: National Institute for Health Research
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Screening

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• Efavirenz
400mg qd; 2 x 200mg
• Efavirenz
600mg qd; 3 x 200mg qd

Locations

Country	Name	City	State
Thailand	HIVNAT Research Collaboration	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Kirby Institute	The HIV Netherlands Australia Thailand Research Collaboration

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the comparison between of neurocognitive function in patients initiating sdEFV and 400EFV		48 weeks	No
Secondary	The association between week 4 plasma EFV levels and change from baseline neurocognitive function to week 4 and 24.		Week 24	No
Secondary	To assess dynamic changes in neurocognitive function over the total duration of follow-up.		96 weeks	No