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Sponsors and Collaborators: |
Neurologic AIDS Research Consortium (NARC) Ortho Biotech Clinical Affairs, L.L.C. PPD National Institute of Neurological Disorders and Stroke (NINDS) Washington University School of Medicine |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00528593 |
The purpose of this study is to evaluate the effect of epoetin alfa on HIV-associated neuropathy by measuring changes in nerve fiber density and pain ratings.
Condition | Intervention | Phase |
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HIV Infections Neuropathy |
Drug: epoetin alfa |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Multi-Center Pilot Study to Evaluate the Efficacy and Safety of Epoetin Alfa (Procrit) in the Treatment of HIV-Associated Sensory Neuropathy |
Estimated Enrollment: | 46 |
Study Start Date: | November 2007 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: epoetin alfa
Group 1 will receive Procrit once every three weeks, and group 2 will receive Procrit every week.
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The Neurologic AIDS Research Consortium (NARC) designs and carries out clinical trials to improve the therapy for HIV induced neurologic disease, and neurologic conditions associated with the AIDS virus.
Complications of HIV are dynamically evolving over time. In general, neurologic complications that typically occur in advanced disease stages are increasing in incidence while some of the early complications associated with AIDS are less commonly found due to improved preventive therapy. The impact of the new generation of antiretroviral drugs, and of predominantly multi-drug therapy remain to be seen. Several key new drugs fail to penetrate the brain, thus making it possible for the incidence of neurologic disease to continue to increase. NARC develops studies based on the current challenges of the AIDS epidemic.
Erythropoetin (also known as epoetin alfa or Procrit) is naturally produced in the body. Procrit or epoetin alfa is an injectable form of synthetic erythropoietin. In this trial, scientists will evaluate the effect of epoetin alfa on HIV-associated neuropathy by measuring changes in nerve fiber density and pain ratings. The goal of the trial is to determine if epoetin alfa increases the number of nerve fibers in the skin of people with HIV-associated neuropathy, and improves symptoms of neuropathy. This study will also find out if Procrit is safe and well-tolerated for treating the painful neuropathy associated with HIV.
After two screening visits, participants will be randomly assigned to one of two groups: group 1 will receive Procrit once every three weeks, and group 2 will receive Procrit every week. Follow-up treatment visits will occur at weeks 6, 12, 24, 36, and 48. During the visits, participants will have their blood pressure and heart rate measured. During several of the follow-up visits participants will be asked to rate the intensity of their pain using the Gracely Pain Scale and the McGill Pain Questionnaire. Duration of this trial for participants is 52 weeks or 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
Northwestern University, Division of Infectious Diseases, 676 N. St. Clair, Suite 200 | |
Chicago, Illinois, United States, 60611 | |
United States, Maryland | |
Johns Hopkins University, Department of Neurology, 600 N. Wolfe Street- Meyer 6-109 | |
Baltimore, Maryland, United States, 21287 | |
United States, Missouri | |
Washington University, Neurologic AIDS Research Consortium, 660 South Euclid, Box 8111 | |
St. Louis, Missouri, United States, 63110 | |
United States, New York | |
Mount Sinai Medical Center, One Gustave Levy Place; Box 1052 | |
New York, New York, United States, 10029 | |
United States, Pennsylvania | |
University of Pennsylvania, Infectious Diseases Section, 502 Johnson Pavillion | |
Philadelphia, Pennsylvania, United States, 19104-6073 |
Study Chair: | Justin McArthur, MBBS, MPH | Professor of Neurology, Johns Hopkins University |
Principal Investigator: | David B. Clifford, MD | Professor of Neurology, Washington University |
Investigator: | David Simpson, MD | Professor of Neurology, Mt. Sinai Medical Center |
Investigator: | Bruce Cohen, MD | Professor of Neurology, Northwestern University |
Investigator: | Pablo Tebas, MD | Associate Professor of Medicine, University of Pennsylvania |
Responsible Party: | Neurologic AIDS Research Consortium, Washington University ( David B. Clifford, M.D., Principal Investigator ) |
Study ID Numbers: | U01 NS32228 |
Study First Received: | September 11, 2007 |
Last Updated: | April 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00528593 |
Health Authority: | United States: Food and Drug Administration |
HIV AIDS neuropathy Procrit |
epoetin alfa erythropoetin Treatment Experienced |
Epoetin Alfa Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Hematinics Therapeutic Uses |
Hematologic Agents Lentivirus Infections Infection Pharmacologic Actions |