None listed
Conditions
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.
Interventions
Lithium (oral capsules), 250 mg twice daily for 12 weeks
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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
Outcome results
None listed