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

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN54452526

Enrollment

124

Registered

2014-11-17

Start date

2009-04-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacological management of painful neuropathy Nervous System Diseases Moderate to severe HIV-related peripheral neuropathy

Interventions

All study participants will receive amitriptyline (titrated to efficacy, side effects or a maximum dose of 150 mg daily) or inert placebo in random order for 6 weeks, with a three-week washout period

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Self-reported pain intensity, assessed on an 11-point numerical pain rating scale.	—

Secondary

Measure	Time frame
1. Pain interference on activities of daily living, assessed using the pain interference sub-scale of the Brief Pain Inventory 2. Physical symptoms, psychological, emotional and spiritual, and information and support needs, assessed using the African Palliative Care Outcomes Scale (APOS) 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.	—

Measure

Time frame

1. Pain interference on activities of daily living, assessed using the pain interference sub-scale of the Brief Pain Inventory 2. Physical symptoms, psychological, emotional and spiritual, and information and support needs, assessed using the African Palliative Care Outcomes Scale (APOS) 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.

—

Countries

South Africa

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026