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

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.