HIV/AIDS Mental and Behavioural Disorders Nervous System Diseases
Conditions
Interventions
Lithium carbonate
Placebo
Sponsors
University of Cape Town
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able to provide written informed consent. 2. HIV-infected male and female participant between 18 and 70 years (inclusive). 3. Currently on ART for at least 6 months. 4. Virologically suppressed on ART. 5. Cognitive impairment. 6. Female participants must have a negative pregnancy test and not be breastfeeding. 7. Females of child-bearing potential must commit to use of contraceptive methods with a failure rate of < 1% per year for the duration of the study. 8. Females not using an acceptable form of contraception must be of non-childbearing potential, surgically sterilized or post-menopausal.
Exclusion criteria
Exclusion criteria: 1. Received an investigational drug within 30 days before the first dose of lithium carbonate. 2. Evidence of an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection within 30 days before the first dose of lithium carbonate. 3. History of drug or alcohol abuse within 3 months before screening. 4. Positive urine drug screen for drugs of abuse at screening. 5. Confirmed neurosyphilis. 6. Confirmed vitamin B12 deficiency. 7. Imaging structural abnormalities. 8. Neuropsychiatric disorders or serious psychiatric symptoms. 9. QTc greater than 450 msec for males and 470 msec for females. 10. Confirmed epilepsy on chronic treatment. 11. Use of any medications that may predispose the participant to lithium toxicity. 12. Clinically significant hypo- or hyperthyroidism. 13. Clinically significant hypercalcaemia or hypermagnesaemia. 14. Renal impairment. 15. Current diarrhoea and dehydration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To measure the change in neuropsychological function as determined by the Global Deficit Score (GDS) from baseline to week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| To measure changes in magnetic resonance spectroscopy (MRS)-based (glutamate and glutamine) Glx in the frontal grey matter and measures of tensor diffusivity (including fractional anisotropy, and radial, axial and mean diffusivity) in white matter from baseline to week 24.;To assess the severity and frequency of adverse events. ;To measure changes in Human immunodeficiency virus (HIV) viral load in the plasma and cerebrospinal fluid (CSF).;To measure changes in CSF:serum albumin ratio.;To measure changes in CSF:serum viral load ratio.;To measure changes in glycogen synthase kinase-3-beta (GSK-3-ß) in human peripheral blood mononuclear cells (PBMC).;To study the effect of lithium on CSF dopamine and peripheral lymphocytes expressing dopamine receptors.;To study the effect of lithium brain-derived neurotrophic factor (BDNF) in serum and CSF. ;To explore outcome measure potential associations with putative biomarkers, inflammatory markers or genes that might be identified during the course of the study. | — |
Countries
South Africa
Contacts
Public ContactEric Decloedt
Outcome results
None listed