A randomized controlled trial of 5% lidocaine gel for HIV-associated distal symmetric polyneuropathy

Lydia Estanislao, Kay Carter, Justin McArthur, Richard Olney, David Simpson

Research output: Contribution to journalArticlepeer-review

61 Scopus citations


Objective: To investigate the analgesic efficacy and safety of 5% lidocaine gel in painful HIV-associated distal sensory polyneuropathy (DSP). Background: Painful DSP, the most common neurologic complication in HIV infection, is difficult to treat. Lidocaine 5% gel was effective in alleviating neuropathic pain in an open-label study of HIV DSP. Methods: In a double-blind, placebo-controlled, crossover, multicenter study, 64 subjects were randomized to receive 5% lidocaine or vehicle gel for 2 weeks (phase A). A washout period of 2 weeks was followed by a crossover to the alternate agent for another 2 weeks (phase B). The primary outcome was difference in average pain scores (Gracely pain scale) between the 2 groups during the second week of each treatment period. Secondary outcomes included differential effect of the first treatment, difference in global pain relief, and pain response by neurotoxin exposure. Results: The baseline pain scores of the 2 groups were similar. The average pain scores during the second week of each phase of the lidocaine gel group did not differ from those of the placebo group (phase A: lidocaine 1.09, placebo 1.15; phase B: lidocaine 1.16, placebo 1.10). There also was no difference noted in secondary outcomes. The pain responses of lidocaine gel-treated subjects with current exposure to neurotoxic antiretrovirals (1.18) did not differ compared with those without (1.10) (P = 0.358). There were no significant adverse effects. Conclusion: Lidocaine 5% gel is a safe but ineffective agent in the treatment of pain in HIV-associated DSP.

Original languageEnglish (US)
Pages (from-to)1584-1586
Number of pages3
JournalJournal of Acquired Immune Deficiency Syndromes
Issue number5
StatePublished - Dec 15 2004


  • HIV
  • Neuropathy
  • Pain
  • Randomized controlled trial

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)


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