Efficacy of Lithium as an Adjunctive Therapy for HIV associated neurocognitive impairment Trial

Withdrawn

• Conditions: HIV associated Mild Neurocognitive Disorder; Neurological - Other neurological disorders; Infection - Acquired immune deficiency syndrome (AIDS / HIV); Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12612000727842
• Lead Sponsor: niversity of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 100

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint for this trial is change in overall neurocognitive function.<br><br>1. Speed of information processing: WAIS-III Digit Symbol; Trail Making Test, Part A<br>2. Learning And Recall: Hopkins Verbal Learning Test-Revised<br>3. Abstraction/Executive functioning: Wisconsin Card Sort Test-64; Trail Making Test, Part B; Stroop Task<br>4. Verbal fluency: Controlled Oral Word Association Test (FAS)<br>5. Attention/Working memory: WMS-III-Spatial Span; PASAT<br>6. Motor: Grooved Pegboard Test (both hands)<br>7. Premorbid Functioning: National Adult Reading Test (NART)[Baseline and 12-weeks post baseline]

Secondary Outcome Measures

Name	Time	Method
As a secondary endpoint we will examine grey and white matter changes based in T1-weighted and T2-weighted imaging sequences.[Baseline and 12-weeks post baseline]