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HIV InfectionsPhase 2NCT00000842

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

A Phase 2 study testing Nerve Growth Factor, Recombinant Human in people with HIV Infections and Peripheral Nervous System Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Nerve Growth Factor, Recombinant Human
How many people
270 participants
Where
14 sitesUnited States
Study dates
Start not givento Feb 1999
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 13Show fewer
  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Johns Hopkins Adult AIDS CRS

    Baltimore, Maryland, 21287

  • Beth Israel Deaconess - East Campus A0102 CRS

    Boston, Massachusetts, 02215

  • Unc Aids Crs

    Chapel Hill, North Carolina, 275997215

  • Northwestern University CRS

    Chicago, Illinois, 60611

  • Case CRS

    Cleveland, Ohio, 44106

  • The Ohio State Univ. AIDS CRS

    Columbus, Ohio, 432101228

  • UCLA CARE Center CRS

    Los Angeles, California, 90095

  • NY Univ. HIV/AIDS CRS

    New York, New York, 10016

  • Cornell University A2201

    New York, New York

  • Univ. of Rochester ACTG CRS

    Rochester, New York, 14642

  • San Mateo County AIDS Program

    San Mateo, California

  • University of Washington AIDS CRS

    Seattle, Washington, 981224304

  • Washington U CRS

    St Louis, Missouri

  • Stanford CRS

    Stanford, California, 943055107

Other trials in United States

About this study

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.

Read the 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.

Being tested
Nerve Growth Factor, Recombinant Human
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Peripheral Nervous System Diseases, Nerve Growth Factors, Growth Substances
Medical subject headings
HIV Infections, Peripheral Nervous System Diseases, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nerve Growth Factor, Recombinant HumanDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionFeb 1999

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
Double blind
Enrolment
270 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000842
Sponsor's protocol ID
ACTG 291
Other IDs
11267
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
4 Nov 2021
Results posted
No

Publications

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

    PubMed 11364013

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

    PubMed 11362992

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

    PubMed 11362404

  • 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.

    PubMed 11834952

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

    PubMed 11362419

  • 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.

    PubMed 10720278

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nerve Growth Factor, Recombinant Human in people with HIV Infections and Peripheral Nervous System Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000842, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.

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