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

NCT00000842 | Completed Phase 2

• 2 other identifiers: ACTG 29111267
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 14

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.

Conditions

HIV Infections; Peripheral Nervous System Disease

Keywords

Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Peripheral Nervous System Diseases; Nerve Growth Factors; Growth Substances

Interventions

Nerve Growth Factor, Recombinant Human DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (14)

UCLA CARE Center CRS

Los Angeles, California, 90095, United States

Location

San Mateo County AIDS Program

San Mateo, California, United States

Location

Stanford CRS

Stanford, California, 943055107, United States

Location

Northwestern University CRS

Chicago, Illinois, 60611, United States

Location

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, 21287, United States

Location

Beth Israel Deaconess - East Campus A0102 CRS

Boston, Massachusetts, 02215, United States

Location

Washington U CRS

St Louis, Missouri, United States

Location

NY Univ. HIV/AIDS CRS

New York, New York, 10016, United States

Location

Cornell University A2201

New York, New York, United States

Location

Univ. of Rochester ACTG CRS

Rochester, New York, 14642, United States

Location

Unc Aids Crs

Chapel Hill, North Carolina, 275997215, United States

Location

Case CRS

Cleveland, Ohio, 44106, United States

Location

The Ohio State Univ. AIDS CRS

Columbus, Ohio, 432101228, United States

Location

University of Washington AIDS CRS

Seattle, Washington, 981224304, United States

Location

Related Publications (6)

• Nerve growth factor study opens. GMHC Treat Issues. 1996 Nov;10(11):9.

  PMID: 11364013 BACKGROUND

• Gilden D. Hyperthermia study finds little effect. GMHC Treat Issues. 1995 Nov;9(11):5-7.

  PMID: 11362992 BACKGROUND

• James JS. Nerve growth factor: major trial canceled, revived after protest. AIDS Treat News. 1995 Apr 21;(no 221):5.

  PMID: 11362404 BACKGROUND

• Simpson DM, Haidich AB, Schifitto G, Yiannoutsos CT, Geraci AP, McArthur JC, Katzenstein DA; ACTG 291 study team. Severity of HIV-associated neuropathy is associated with plasma HIV-1 RNA levels. AIDS. 2002 Feb 15;16(3):407-12. doi: 10.1097/00002030-200202150-00012.

  PMID: 11834952 BACKGROUND

• Lein B. Potential therapy for painful neuropathy. PI Perspect. 1995 May;(no 16):11.

  PMID: 11362419 BACKGROUND

• McArthur JC, Yiannoutsos C, Simpson DM, Adornato BT, Singer EJ, Hollander H, Marra C, Rubin M, Cohen BA, Tucker T, Navia BA, Schifitto G, Katzenstein D, Rask C, Zaborski L, Smith ME, Shriver S, Millar L, Clifford DB, Karalnik IJ. A phase II trial of nerve growth factor for sensory neuropathy associated with HIV infection. AIDS Clinical Trials Group Team 291. Neurology. 2000 Mar 14;54(5):1080-8. doi: 10.1212/wnl.54.5.1080.

  PMID: 10720278 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Peripheral Nervous System Diseases; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Nerve Growth Factor

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neuromuscular Diseases; Nervous System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Nerve Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Nerve Tissue Proteins; Biological Factors

Study Officials

• McArthur J

  STUDY CHAIR

• Simpson D

  STUDY CHAIR

• Schifitto G

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: February 1, 1999
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (14)