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A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy Clinical research trials and A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy. A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy clinical trial. Subjects often receive the most expert healthcare possible for their A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy  A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy
A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy
For Condition: HIV Infections,Peripheral Nervous System Disease
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 270
Location and Contact Information:
Overall Study Official:
McArthurJ, Study Chair,
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ of Kentucky Lexington
Cincinnati, Ohio, 45267
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Additional Information:
Study ID Numbers: ACTG 291;
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000842
Other Hiv Infections Studies:
1. A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection
2. (1)H-Nuclear Magnetic Resonance Spectroscopic Imaging of the Brain in Patients who Receive Neurotoxic Therapy
3. Intranasal Peptide T in the Treatment of Painful Peripheral Neuropathy of AIDS
4. Study of Inherited Neurological Disorders
5. Nerve Damage in Patients with HIV Infection Who Have Been Treated with Anti-HIV Drugs
Related Studies:
Other HIV Infections Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy
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