Double blind randomised controlled trial to assess the effectiveness of amitriptyline compared to placebo in the management of moderate to severe HIV related peripheral neuropathy.

Diana Princess of Wales Memorial Fund (UK)0 个研究点目标入组 124 人开始时间: 2014年11月17日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•1. Confirmed and documented HIV positive status, either on Arv therapy or not on ARV therapy
•2. Diagnosed with moderate to severe peripheral neuropathy using the BPNS and DN4 screening
•tools and scoring >/= 4 on an 11 point Likert scale visual analogue scale
•3. Age above 18 on the date of recruitment
•4. Ability to mentally and physically understand to make informed choice to participate in the study

•All conditions which are likely to cause confounding will be excluded from the study, together with
•conditions which are likely to cause drug interactions.
•1. Severe pain from DSN caused by ARV drugs which warrants a change in regime
•2. Already taking amitriptyline drug, or has taken the drugs at least three weeks prior
•3. Limb amputation
•4. Kaposi sarcoma of the lower limbs
•5. Current post-herpetic neuralgia or herpes zoster
•6. Pregnancy or intention to fall pregnant
•7. TB treatment
•8. Malignancy not related to HIV
•9. Major psychiatric disorders including mania or epilepsy
•10. Clinically significant renal failure
•11. Diabetic neuropathy
•12. Clinically significant liver failure or past history as defined by encephalopathy, oedema and jaundice
•13. Patient in extreme pain or exhausted
•14. Participating on another trial or study
•15. MAOI, other tricyclic antidepressants or anti-epileptic drugs
•16. Recent myocardial infarction, arrhythmias, heart block
•17. History of urinary retention, urinary hesitancy or closed angle glaucoma

发起方

Diana Princess of Wales Memorial Fund (UK)