The purpose of this study is to determine the safety, tolerability and efficacy of pain relief of recombinant human nerve growth factor (rhNGF) for HIV-associated sensory neuropathy. Peripheral neuropathies are commonly seen in patients with HIV infection. Data from the Multi-center AIDS Cohort Study suggest that the incidence of sensory neuropathy is increasing rapidly. Autopsies have demonstrated evidence of peripheral nerve damage in 100% of patients dying from AIDS. Up to 30% of all patients with advanced HIV infection develop symptomatic peripheral neuropathy with pain, paresthesias and dyesthesias in the lower extremities. Although painful sensory neuropathy is not life threatening, it greatly affects the quality of life and adds significantly to the morbidity of HIV infection. The pathogenetic mechanisms underlying painful sensory neuropathy are not fully understood. It appears that macrophage- mediated infiltration of the peripheral nerve with local cytokine release and the development of length-dependent distal axonal degeneration is universal in patients with painful sensory neuropathy. Both large and small fibers are affected and show degeneration signs in a centripetal fashion. Until now, treatments have been symptomatic for HIV-associated sensory neuropathy, relying on pain modifying agents or membrane stabilizing drugs. Due to the prominence of the degeneration of the small nerve fibers which are known to be rhNGF-responsive, rhNGF is proposed as a specific restorative treatment for HIV-associated sensory neuropathy.
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