Search / Trial NCT00000842

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of September 11, 2024

Completed

Keywords

Acquired Immunodeficiency Syndrome Aids Related Complex Peripheral Nervous System Diseases Nerve Growth Factors Growth Substances

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 th...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • * Maintenance treatment of CMV retinitis, MAI bacteremia, or cryptococcal meningitis is permitted.
  • * Local therapy for Kaposi's sarcoma.
  • Patients must have:
  • * Evidence of HIV antibodies documented by a licensed ELISA and a second, FDA-approved, confirmatory test.
  • * Diagnosis of HIV-associated, predominantly sensory neuropathy by a neurologist.
  • * Willingness and ability to complete the pain and medication log and competence to assess pain level throughout the study.
  • Prior Medication:
  • Allowed:
  • * History of stable-dose (defined as no more than 50% increase or decrease in dose) antiretroviral therapy for eight weeks before randomization, including the following:
  • * didanosine, zalcitabine, stavudine, lamivudine, protease inhibitors, and antiretrovirals available through expanded access trials.
  • * Chemotherapeutic drugs other than neurotoxic systemic chemotherapeutic agents within 30 days prior to randomization.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • * Presence of acute, active, opportunistic infection, except oral thrush; oral, genital or rectal herpes; and MAI bacteremia within two weeks before randomization.
  • * Evidence of another contributing cause for peripheral neuropathy, including:
  • * diabetes mellitus, hereditary neuropathy, current vitamin B12 deficiency and no supplementation or supplementation \<= 3 months, or treatment with any drug that might contribute to sensory neuropathy.
  • * Major active psychiatric disorder (depression is allowed provided patient has received a stable antidepressant regimen for at least four weeks before randomization).
  • * Current active malignancy. NOTE: Malignancies in remission that do not require further treatment or Kaposi's sarcoma requiring only local treatment are allowed.
  • * Any conditions, including dementia and myelopathy, that would interfere with patient evaluation, accurate completion of the symptom scale, or compliance with subcutaneous injection.
  • Concurrent Medication:
  • Excluded:
  • * Chemotherapeutic agents.
  • * Systemic corticosteroids or immunomodulators.
  • * Initiation of new antiretroviral to a stable regimen.
  • Prior Medication:
  • Excluded:
  • * Neurotoxic systemic chemotherapy within the past 90 days.
  • * Systemic corticosteroids or immunomodulators within the past 30 days.
  • * Initiation of non-opioid prescription medication for pain during the 2 weeks preceding randomization (including tricyclic antidepressants, mexiletine, phenytoin, and carbamazepine).
  • * Treatment for acute opportunistic infections within the past 14 days (maintenance therapy for CMV retinitis, MAI bacteremia, or cryptococcal meningitis is permitted).
  • Active drug or alcohol abuse that would affect study compliance.

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Los Angeles, California, United States

San Mateo, California, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Saint Louis, Missouri, United States

New York, New York, United States

New York, New York, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Seattle, Washington, United States

Stanford, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0