This is a phase II, multicenter, randomized, double-blind, placebo- controlled trial of the safety, tolerability and efficacy of pain relief of lamotrigine for HIV-associated sensory neuropathy. Peripheral neuropathy is a common complication of HIV infection. HIV-associated sensory neuropathy is a common form of neuropathy in advanced HIV infection. Approximately 30% of patients with AIDS develop HIV-associated sensory neuropathy. Symptoms can be painful and can greatly impact on the activities of daily living as well as the quality of life. A direct viral etiology has been postulated as a causative agent. Certain antiretrovirals (ddI, ddC, d4T) are also known to cause neuropathy in this patient population. Therapeutic treatment of painful sensory neuropathy has been difficult. Current management involves the use of sympomatic or pain-modifying agents. Symptomatic relief with tricyclic antidepressants, non-steroidal anti-inflammatory agents, topical capsaicin or opiates has been limited. A trial is currently underway with a potentially restorative agent, nerve growth factor. Lamotrigine is a newly approved anti-convulsant which blocks voltage sensitive sodium channels, resulting in inhibition of glutamate and aspartate release. Lamotrigine has similar efficacy in maximal electro- shock models to carbamazepine and phenytoin, both of which have proven efficacious for the treatment of painful diabetic neuropathy. To date, there have only been anectodal reports of the efficacy of lamotrigine for treatment of HIV-associated sensory neuropathy.

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Johns Hopkins University
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