A randomised controlled trial of lithium carbonate in individuals with HIV clade C-associated neurocognitive impairment: a phase IIb proof of principle study.

niversity of Cape Town0 个研究点目标入组 108 人开始时间: 2013年8月30日最近更新: 2023年5月29日

试验速览

暂无简介。

•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.

•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.

发起方

niversity of Cape Town