Neurologic Aids Research Consortium (NARC 00 9)

  • Berger, Joseph (PI)

Grants and Contracts Details


Participation in this protocol will entail entry of research subjects into a 6-week double-blind randomized study phase using 4 doses of prosaptide or placebo, followed by a 2 week double-blind crossover phase. Three hundred ninety (390) HIV positive subjects, on a stable antiretroviral regimen, with evidence of HIV-associated sensory neuropathy will be emolled. There will be eight required visits during the study (two screening visits and weeks 0, 1,3,5, 7 and 9). The primary objective of the study is to determine the efficacy of2, 4, 8, and 16 mg per day of pros aptide compared to placebo in subjects with painful HIV-associated sensory neuropathy (DSPN or ATN). This is a neurologic study requiring the participation of a neurologist. In addition to the screening neurologic evaluation, as defined in the protocol, a neurologic assessment is required at the start of study drug, crossover, and study completion. . Nerve conduction testing will occur during the screening phase and at the crossover visit.
Effective start/end date8/1/037/31/04


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