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. This will be a randomized, double-blind, placebo-controlled multicenter study design using four dosing levels (2, 4, 8, and 16 mg/day) to evaluate the efficacy and safety of prosaptide for the relief of neuropathic pain associated with HIV-1. An interim analysis will be performed when 200 subjects complete 6 weeks of treatment. Subjects will be washed out of adjuvant pain medications including anticonvulsants, antidepressants, topical analgesics, and short acting-narcotics. Long acting opioid analgesics (maintained at a constant daily dose throughout the study) will be permitted in up to 20% of screened subjects at each study site. Subjects taking long-acting narcotics must have received a constant daily dose for at least 90 days prior to Visit 1. All subjects will receive a supply of acetaminophen 500 mg tablets as rescue medication. Subjects who have intolerable pain despite rescue medication are permitted to discontinue from the study at any time. The double-blind phase will include a 6 week active treatment phase with subjects receiving one of 4 dosing levels of prosaptide or placebo.
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