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

Phase 2

Completed

• Conditions: HIV Infections; Peripheral Nervous System Disease

• Registration Number: NCT00000842
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief 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.

Detailed Description

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.

Patients are randomized to receive either rhNGF at one of two doses or placebo, administered subcutaneously twice weekly for 18 weeks. Patients are stratified into three groups within their regimens by use of didanosine, zalcitabine, or stavudine as follows: current use vs. discontinued between 8 and 26 weeks before randomization vs. never used or discontinued use at least 26 weeks before randomization. Patients will assess their pain daily using the Gracely Pain Scale. AS PER AMENDMENT 5/6/97: After completion of the double-blind phase (18 weeks on treatment followed by 4 weeks off treatment), patients may receive open-label, active drug treatment according to their previously assigned regimen for an additional 48 weeks.

Study Timeline

• Study Completion: 1999-02
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (14)

UCLA CARE Center CRS; 🇺🇸 Los Angeles, California, United States

Northwestern University CRS; 🇺🇸 Chicago, Illinois, United States

Johns Hopkins Adult AIDS CRS; 🇺🇸 Baltimore, Maryland, United States

San Mateo County AIDS Program; 🇺🇸 San Mateo, California, United States

Stanford CRS; 🇺🇸 Stanford, California, United States

Beth Israel Deaconess - East Campus A0102 CRS; 🇺🇸 Boston, Massachusetts, United States

Washington U CRS; 🇺🇸 Saint Louis, Missouri, United States

NY Univ. HIV/AIDS CRS; 🇺🇸 New York, New York, United States

Univ. of Rochester ACTG CRS; 🇺🇸 Rochester, New York, United States

Cornell University A2201; 🇺🇸 New York, New York, United States

Unc Aids Crs; 🇺🇸 Chapel Hill, North Carolina, United States

Case CRS; 🇺🇸 Cleveland, Ohio, United States

The Ohio State Univ. AIDS CRS; 🇺🇸 Columbus, Ohio, United States

University of Washington AIDS CRS; 🇺🇸 Seattle, Washington, United States