Data and analysis scripts: Amitriptyline for the management of painful HIV-associated sensory neuropathy (HIV-SN)

Citation: Dinat N, Marinda E, Moch S, Rice AS, Kamerman PR. Randomized, double-blind, crossover trial of amitriptyline for analgesia in painful HIV-associated sensory neuropathy. PLoS One 10(5):e0126297. DOI:10.1371/journal.pone.0126297, PMID: 25974287

Repo content: Data, codebooks, and analysis scripts for a randomized, double-blind, placebo-controlled, cross-over clinical trial of amitriptyline for the management of moderate to severe pain associated with HIV-associated sensory neuropathy. 

Background and study aims: The peripheral nervous system is part of the nervous system that is made up of the nerves and ganglia (group of nerve cells) outside of the brain and spinal cord (the central nervous system). It connects the central nervous system to the limbs and organs of the body. Damage to peripheral nerves, especially the long nerves of the feet and hands, is common in people infected with HIV. This damage may be caused by the virus itself, some of the antiretroviral drugs used to treat HIV/AIDS, or as a result of opportunistic infections, for example thrush, herpes and tuberculosis. The nerve damage is often painful, can have a detrimental effect on a person's quality of life and has significant socioeconomic effects. Unlike other types of peripheral neuropathy (e.g., the neuropathy that develops in people with diabetes mellitus), there are, as yet, no effective treatments for painful HIV neuropathy. Here, we want to see if amitriptyline, an antidepressant drug that has been shown to relieve pain in other types of neuropathy, can provide pain relief better than that of a placebo (a dummy pill) in patients with painful HIV neuropathy. 

Who participated? Adult HIV-infected individuals that have been diagnosed with painful HIV-associated sensory 

neuropathy. Participants were either be on stable antiretroviral therapy, or had never been exposed to antiretroviral therapy for HIV infection.

What did the study involve? Ambulatory HIV-positive patients attending clinics at Chris Hani Baragwanath Hospital, Soweto, South Africa were randomly allocated to receive amitriptyline (25-150mg/day) or a placebo for six weeks. The drug/placebo dose was started at 25mg/day and increased every three days over the first two weeks of the treatment until participants achieve pain relief, intolerable side effects, or a maximum dose of 150 mg/day. The trial drug and the placebo were identical in appearance. Participants visit the study centre every three weeks to receive their medication and to record a pain score. At the end of the first six-week treatment period, participants are taken off their assigned medication for a three-week 'washout' period. After this washout period, those participants who receive amitriptyline before were now given the placebo and vice versa for another 6 weeks. Dose titration and pain assessments followed the same protocol used in the first six-week period.

Where was the study run from? Nthabiseng HIV Clinic and the Centre for Palliative Care, Chris Hani Baragwanath Hospital, Soweto, South Africa

What was the study outcome? Amitriptyline was not superior to placebo at relieving moderate-to-severe pain in individuals with HIV-SN.