This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The most frequent neurological complication of HIV infection and its treatment is peripheral neuropathy. To date, there are few effective treatments for HIV-associated peripheral neuropathy. Prosaptide is a 14- amino acid polypeptide that has been effective in treating neuropathic pain caused by a variety of different mechanisms in preclinical animal models, including diabetes. Though the systemic damage occurs in a different process in diabetes than in HIV, the neuropathic pain syndrome end result is the same. This will be a multicenter, randomized, double-blind, 13-week placebo-controlled study to evaluate the effects of 2, 4, 8 and 16mg per day doses of prosaptide on neurologic pain in HIV-associated sensory neuropathies. Participants will remain on their prosaptide treatment for 6 weeks. This will be followed by a 2-week double-blind crossover period during which participants previously receiving active treatment will receive placebo injections. The group receiving placebo during the 6 weeks will be crossed over to receive prosaptide 4 mg for 2 weeks. Prosaptide study medication throughout the study will be administered in the form of daily subcutaneous injections. It is hypothesized that prosaptide will: 1) improve neuropathic pain in HIV-associated sensory neuropathies (distal symmetric peripheral neuropathy (DSPN) or antiretroviral toxic neuropathy (ATN)) and 2) be safe and well tolerated in subjects with HIV-associated sensory neuropathies (DSPN or ATN).
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