A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy
Status:
Completed
Trial end date:
1999-02-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)