The purpose of this study is to evaluate the efficacy and safety of lamotrigine for the treatment of pain in subjects with HIV-peripheral neuropathy. Peripheral neuropathy is a frequent late-stage complication of HIV infection. The most common form is a symmetric, predomininately sensory, distal polyneuropathy that affects 20-35% of patients with late-stage HIV infection. The clinical signs and symptoms of HIV peripheral neuropathy (HIV-PN) include pain, numbness, and burning sensations primarily in the feet. The cause of HIV-PN remains unknown. A number of medications have been used in the treatment of HIV-PN, including antidepressants, anticonvulsants, opiate and non-opiate analgesics and local anesthetics. All of these have variable and generally incomplete efficacy. Lamotrigine is an anticonvulsant with similar efficacy in maximal electroshock models to carbamazepine and phenytoin, both with proven benefit in the treatment of painful diabetic neuropathy. The proposed mechanism of action of lamotrigine is a blocking effect on voltage-sensitive sodium channels and inhibition of glutatmate and aspartate release. An excess of these excitotoxins may play a role in AIDS neuropathy. Anecdotal reports and published data from small, uncontrolled clinical trials suggest that lamotrigine may be an effective treatment for neuropathic pain. These results suggest a larger study is warranted.
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