Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000622808
Ethics application status
Approved
Date submitted
21/02/2012
Date registered
8/06/2012
Date last updated
8/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public 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-naive HIV-Infected Individuals Over 96 Weeks
Scientific title
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-naive HIV-infected Individuals Over 96 Weeks
Secondary ID [1] 279988 0
NCT01516060 ClinicalTrials.gov
Universal Trial Number (UTN)
Trial acronym
The Neurocoginitive sub study of Encore1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 285897 0
Condition category
Condition code
Infection 286088 286088 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tenofovir (TDF) (300mg qd(once daily)/emtricitabine(FTC) (200mg qd) + efavirenz(EFV )(400mg qd; 2 x 200mg + 1 x placebo qd) all oral tablets

http://clinicaltrials.gov/ct2/show/NCT01516060?term=Encore1&rank=4
Intervention code [1] 284315 0
Treatment: Drugs
Comparator / control treatment
Tenofovir (TDF) (300mg qd)/emtricitabine (FTC) (200mg qd) + efavirenz(EFV )(600mg qd; 3 x 200mg qd) all oral tablets
Control group
Dose comparison

Outcomes
Primary outcome [1] 286565 0
The primary endpoint is the comparison between neurocognitive function in patients initiating sdEFV and 400EFV

Neurocognitive function will be assessed by using a the CogState Battery, computer software designed to assess neurocognitive function
Timepoint [1] 286565 0
48 weeks
Secondary outcome [1] 296180 0
The association between week 4 plasma EFV levels and change from baseline neurocognitive function to week 4 and 24.
Timepoint [1] 296180 0
24 weeks

Eligibility
Key inclusion criteria
All subjects entering into the main study protocol at participating centres will be eligible to enter this sub-study
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (ie computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
124
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5018 0
2010
Recruitment outside Australia
Country [1] 4139 0
United Kingdom
State/province [1] 4139 0
London
Country [2] 4140 0
Germany
State/province [2] 4140 0
Berlin
Country [3] 4141 0
Germany
State/province [3] 4141 0
Bonn
Country [4] 4142 0
Israel
State/province [4] 4142 0
Haifa
Country [5] 4143 0
South Africa
State/province [5] 4143 0
Johannesburg
Country [6] 4144 0
Mexico
State/province [6] 4144 0
Mexico City
Country [7] 4145 0
Argentina
State/province [7] 4145 0
Buenos Aires
Country [8] 4146 0
Malaysia
State/province [8] 4146 0
Kuala lumpur
Country [9] 4147 0
Hong Kong
State/province [9] 4147 0
Hong Kong
Country [10] 4148 0
India
State/province [10] 4148 0
Chennai
Country [11] 4149 0
Thailand
State/province [11] 4149 0
Bangkok

Funding & Sponsors
Funding source category [1] 284747 0
Self funded/Unfunded
Name [1] 284747 0
Country [1] 284747 0
Primary sponsor type
University
Name
Kirby Institute, Univeristy of New South Wales
Address
Gate 9
High Street
Kennsington
Univeristy of New South Wales
Sydney
NSW 2052
Country
Australia
Secondary sponsor category [1] 283639 0
None
Name [1] 283639 0
Address [1] 283639 0
Country [1] 283639 0
Other collaborator category [1] 260558 0
Other Collaborative groups
Name [1] 260558 0
The HIV Netherlands Australia Thailand Research Collaboration
Address [1] 260558 0
The Netherlands, Australia, Thailand Research Collaboration
104 Ratchdumri Road Pathumwan,
Bangkok 10330, Thailand
Country [1] 260558 0
Thailand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286751 0
St Vincents Hospital
Ethics committee address [1] 286751 0
390 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 286751 0
Australia
Date submitted for ethics approval [1] 286751 0
Approval date [1] 286751 0
19/12/2011
Ethics approval number [1] 286751 0
HREC/10/SVH/34

Summary
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

http://clinicaltrials.gov/ct2/show/NCT01516060?term=Encore1&rank=4
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33808 0
Address 33808 0
Country 33808 0
Phone 33808 0
Fax 33808 0
Email 33808 0
Contact person for public queries
Name 17055 0
Anna Donaldson
Address 17055 0
Gate 9
High Street
Kennsington
Univeristy of New South Wales
Sydney NSW
2052
Country 17055 0
Australia
Phone 17055 0
+61293850900
Fax 17055 0
+6129385 0920
Email 17055 0
[email protected]
Contact person for scientific queries
Name 7983 0
Dr Rebekah Puls
Address 7983 0
Gate 9
High Street
Kennsington
Univeristy of New South Wales
Sydney NSW
2052
Country 7983 0
Australia
Phone 7983 0
+61293850900
Fax 7983 0
+6129385 0920
Email 7983 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.