To determine the effectiveness of amitriptyline compared to placebo in the management of moderate to severe HIV related peripheral neuropathy.

Not Applicable

Completed

• Conditions: Pharmacological management of painful neuropathy; Nervous System Diseases; Moderate to severe HIV-related peripheral neuropathy

• Registration Number: ISRCTN54452526
• Lead Sponsor: Diana Princess of Wales Memorial Fund (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-17
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-reported pain intensity, assessed on an 11-point numerical pain rating scale.

Secondary Outcome Measures

Name	Time	Method
1. Pain interference on activities of daily living, assessed using the pain interference sub-scale of the Brief Pain Inventory <br>2. Physical symptoms, psychological, emotional and spiritual, and information and support needs, assessed using the African Palliative Care Outcomes Scale (APOS)<br><br>Primary and secondary outcomes were measured at baseline, three and six weeks for each of the two intervention periods. Across the duration of the study, that represents measurements at 0, 3, 6, 9, 12, and 15 weeks on each participant.