Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000727842
Ethics application status
Approved
Date submitted
5/07/2012
Date registered
6/07/2012
Date last updated
17/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of Lithium as an Adjunctive Therapy for HIV associated neurocognitive impairment Trial
Scientific title
Efficacy of lithium as an adjunctive therapy to antiretroviral regimens in treating HIV associated Mild Neurocognitive Disorder
Secondary ID [1] 280792 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ELATe
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV associated Mild Neurocognitive Disorder 286846 0
Condition category
Condition code
Neurological 287165 287165 0 0
Other neurological disorders
Infection 287175 287175 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Mental Health 287176 287176 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lithium (oral capsules), 250 mg twice daily for 12 weeks
Intervention code [1] 285215 0
Treatment: Drugs
Comparator / control treatment
Placebo (microcellulose capsule)
Control group
Placebo

Outcomes
Primary outcome [1] 287466 0
The primary endpoint for this trial is change in overall neurocognitive function.

1. Speed of information processing: WAIS-III Digit Symbol; Trail Making Test, Part A
2. Learning And Recall: Hopkins Verbal Learning Test-Revised
3. Abstraction/Executive functioning: Wisconsin Card Sort Test-64; Trail Making Test, Part B; Stroop Task
4. Verbal fluency: Controlled Oral Word Association Test (FAS)
5. Attention/Working memory: WMS-III-Spatial Span; PASAT
6. Motor: Grooved Pegboard Test (both hands)
7. Premorbid Functioning: National Adult Reading Test (NART)
Timepoint [1] 287466 0
Baseline and 12-weeks post baseline
Secondary outcome [1] 298218 0
As a secondary endpoint we will examine grey and white matter changes based in T1-weighted and T2-weighted imaging sequences.
Timepoint [1] 298218 0
Baseline and 12-weeks post baseline

Eligibility
Key inclusion criteria
Participants must meet all of the following inclusion criteria to participate in this study:
1. HIV-positive
2. Age 18-65 years
3. Diagnosis of Asymptomatic Neurocognitive Impairment or Mild Neurocognitive Disorder
4. Karnofsky score > 49
5. Stable cART for at least 12 weeks prior to study entry
6. English fluency
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All participants meeting any of the following exclusion criteria at baseline will be excluded from study participation:
1. Current bipolar disorder, major depressive disorder, schizophrenia
2. Creatinine > 110 umol/L or Urea >8.0 mmol/L (i.e. significant renal disease)
3. Clinically significant cardiovascular, renal, or thyroid disease
4. Neurologic diseases other than HIV-associated neurocognitive impairment that are known to affect cognition
5. Pregnant or nursing women
6. Untreated or unstable psychiatric illness
7. Severe pre-morbid psychiatric illness
8. Active alcohol or drug abuse
9. Active, symptomatic, opportunistic infections
10. Absolute neutrophil count < 500 cells/micro litres
11. Currently taking precautionary or prohibited medications

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/08/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 285581 0
Commercial sector/Industry
Name [1] 285581 0
Abbott
Country [1] 285581 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Royal Melbourne Hospital
Department of Psychiatry
Level 1 North
Parkville, VIC 3050
Country
Australia
Secondary sponsor category [1] 284411 0
None
Name [1] 284411 0
Address [1] 284411 0
Country [1] 284411 0
Other collaborator category [1] 276915 0
Hospital
Name [1] 276915 0
Alfred Hospital
Address [1] 276915 0
Department of Infectious Diseases
Commercial Road, Melbourne, Victoria 3004
Country [1] 276915 0
Australia
Other collaborator category [2] 276916 0
Hospital
Name [2] 276916 0
St. Vincent's Hospital
Address [2] 276916 0
Department of Neurology
Level 4 Xavier Building
Victoria St Darlinghurst, Sydney, NSW 2010
Country [2] 276916 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300990 0
Alfred Health
Ethics committee address [1] 300990 0
55 Commercial Rd, Melbourne VIC 3004, Australia
Ethics committee country [1] 300990 0
Australia
Date submitted for ethics approval [1] 300990 0
24/11/2011
Approval date [1] 300990 0
07/02/2012
Ethics approval number [1] 300990 0
437/11

Summary
Brief summary
The purpose of this study is to investigate the efficacy of lithium as an adjunctive therapy to combined antiretroviral therapy in alleviating HIV associated neurocognitive impairment. We are also investigating whether lithium protects against brain changes that have also been observed in HIV associated neurocognitive impairment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34399 0
Prof Ian Everall
Address 34399 0
University of Melbourne
Grattan Street, Parkville VIC 3010
Country 34399 0
Australia
Phone 34399 0
+61 3 8344 5509
Fax 34399 0
Email 34399 0
[email protected]
Contact person for public queries
Name 17646 0
Chad Bousman
Address 17646 0
Royal Melbourne Hospital
Department of Psychiatry
Level 1 North
Parkville, VIC 3050
Country 17646 0
Australia
Phone 17646 0
+610390356667
Fax 17646 0
Email 17646 0
[email protected]
Contact person for scientific queries
Name 8574 0
Chad Bousman
Address 8574 0
Royal Melbourne Hospital
Department of Psychiatry
Level 1 North
Parkville, VIC 3050
Country 8574 0
Australia
Phone 8574 0
+610390356667
Fax 8574 0
Email 8574 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.