Trial ID or NCT#

NCT00000842

Status

not recruiting iconNOT RECRUITING

Purpose

To assess the efficacy, safety, and tolerability of recombinant human nerve growth factor ( rhNGF ) in the treatment of HIV-associated sensory neuropathy. AS PER AMENDMENT 5/6/97: To compare the change in viral load between the double-blind phase baseline and week 4 in placebo and active rhNGF recipients. To ensure that rhNGF does not induce an increase in viral load compared with viral load changes seen with placebo. Up to now, treatments for HIV-associated sensory neuropathy have been symptomatic, relying on pain-modifying agents or membrane-stabilizing drugs. Because nerve growth factor is important in the development and maintenance of sympathetic and sensory neurons and their outgrowths, it is proposed that recombinant human nerve growth factor may provide a specific restorative treatment for HIV-associated painful sensory neuropathy.

Official Title

A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy

Eligibility Criteria

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Sanjiv Sam Gambhir, MD, PhD

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CONTACT

SPECTRUM