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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00017771 |
The purpose of this study is to find out what might increase nerve damage in people with HIV who have taken drugs for treatment of HIV disease. Another purpose is to see if nerve exams are done correctly before clinical research sites enroll HIV-infected patients.
Nerve damage is common in patients with HIV infection and can cause serious problems. The factors that place patients at risk are not well understood. This study will examine these factors in patients with advanced HIV infection and who have been taking anti-HIV drugs.
Condition |
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HIV Infections Peripheral Nervous System Disease |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | A Pathophysiologic Study of Development of Distal Symmetrical Polyneuropathy in Individuals With Advanced HIV-1 Infection and Prior Antiretroviral Exposure |
Blood collection
Enrollment: | 100 |
Study Start Date: | June 2001 |
Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
Neurological complications in HIV infection are common and are significant sources of mortality and morbidity. The associated risk factors have not been clearly defined. Several studies have patients who are suited for analysis of peripheral neuropathy and can address the important clinical question of when a subject with asymptomatic neuropathy is most at risk for progressing to painful neuropathy. Some patients in this population with advanced HIV disease will likely have asymptomatic peripheral neuropathy at baseline, and will present an excellent opportunity for prospective study. Detailed quantitative assessments will be carried out to determine the incidence and course of peripheral neuropathy in this population. Risk factors for the development of new peripheral neuropathy, worsening of existing neuropathy, and progression to symptomatic peripheral neuropathy, such as CD4+ cell counts, HIV-1 viral load, and prior nucleoside analogue use, will be evaluated. The potential additive neurotoxic effects of hydroxyurea exposure in this population can also be analyzed.
HIV-infected patients are characterized for the presence or absence of neuropathy at [AS PER AMENDMENT 03/05/02: screening], baseline, Week 24, and Week 48. Entry variables are analyzed to determine predictors of progression from asymptomatic to symptomatic neuropathy or for worsening of symptomatic neuropathy. HIV-uninfected control volunteers have 1 visit [AS PER AMENDMENT 03/05/02: or 2 visits] for nerve conduction and Quantitative Sensory Testing (QST) evaluations to demonstrate proficiency with the testing methods prior to the enrollment of HIV-infected patients. HIV-infected patients are evaluated with the components of the Total Neuropathy Score (TNS) which includes signs (motor function, sensory function, and reflexes), symptoms (motor symptoms and sensory symptoms), QST (CASE IV - vibratory, cooling, and heat pain thresholds), and nerve conduction studies (sural nerve and peroneal nerve). Other evaluations include the Gracely Pain Scale and Visual Analog Scale pain diaries, paired skin biopsies from the right thigh and distal leg (total of 2), and peripheral blood lymphocyte analysis for quantitation of mitochondrial DNA content at entry and final study visit.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
HIV-infected individuals who have previously undergone HIV treatment. HIV-uninfected to be used as controls.
Inclusion Criteria
Control volunteers will be eligible for this study if they:
Patients will be eligible for this study if they:
Exclusion Criteria
Control volunteers will not be eligible for this study if they:
Patients will not be eligible for this study if they:
This study has been changed to modify the exclusion criteria. Earlier versions did not include some of these exclusion criteria.
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
UCLA CARE Ctr | |
Los Angeles, California, United States, 90095 | |
United States, Colorado | |
Univ of Colorado Health Sciences Ctr | |
Denver, Colorado, United States, 80262 | |
United States, Hawaii | |
Univ of Hawaii | |
Honolulu, Hawaii, United States, 96816 | |
United States, Illinois | |
The CORE Ctr | |
Chicago, Illinois, United States, 60612 | |
United States, Indiana | |
Indiana Univ Hosp | |
Indianapolis, Indiana, United States, 462025250 | |
Methodist Hosp of Indiana / Life Care Clinic | |
Indianapolis, Indiana, United States, 46202 | |
Wishard Hosp | |
Indianapolis, Indiana, United States, 46202 | |
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21287 | |
United States, Missouri | |
Washington Univ School of Medicine | |
St Louis, Missouri, United States, 63108 | |
Washington Univ / St Louis Connect Care | |
Saint Louis, Missouri, United States, 63108 | |
United States, New York | |
Univ of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
Cornell Univ Med Ctr | |
New York, New York, United States, 10021 | |
Beth Israel Med Ctr | |
New York, New York, United States, 10003 | |
United States, Pennsylvania | |
Univ of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
Mount Sinai Med Ctr | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Texas | |
Univ of Texas, Southwestern Med Ctr of Dallas | |
Dallas, Texas, United States, 75390 | |
United States, Washington | |
Univ of Washington | |
Seattle, Washington, United States, 98104 |
Study Chair: | David Simpson |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | ACTG A5117, AACTG A5117 |
Study First Received: | June 11, 2001 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00017771 |
Health Authority: | United States: Federal Government |
HIV-1 CD4 Lymphocyte Count Risk Factors Hydroxyurea Disease Progression Alcohol Drinking |
Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load Polyneuropathies Treatment Experienced |
Sexually Transmitted Diseases, Viral Hydroxyurea Acquired Immunodeficiency Syndrome Polyneuropathies Disease Progression Alcohol Drinking Immunologic Deficiency Syndromes |
Virus Diseases Neuromuscular Diseases HIV Infections Peripheral Nervous System Diseases Sexually Transmitted Diseases Retroviridae Infections Ethanol |
Communicable Diseases RNA Virus Infections Slow Virus Diseases Immune System Diseases |
Nervous System Diseases Lentivirus Infections Infection |