Nerve Damage in Patients With HIV Infection Who Have Been Treated With Anti-HIV Drugs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00017771
First received: June 11, 2001
Last updated: July 26, 2013
Last verified: July 2013

June 11, 2001
July 26, 2013
June 2001
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Complete list of historical versions of study NCT00017771 on ClinicalTrials.gov Archive Site
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Nerve Damage in Patients With HIV Infection Who Have Been Treated With Anti-HIV Drugs
A Pathophysiologic Study of Development of Distal Symmetrical Polyneuropathy in Individuals With Advanced HIV-1 Infection and Prior Antiretroviral Exposure

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Blood collection

Non-Probability Sample

HIV-infected individuals who have previously undergone HIV treatment. HIV-uninfected to be used as controls.

  • HIV Infections
  • Peripheral Nervous System Disease
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Simpson DM, Kitch D, Evans SR, McArthur JC, Asmuth DM, Cohen B, Goodkin K, Gerschenson M, So Y, Marra CM, Diaz-Arrastia R, Shriver S, Millar L, Clifford DB; ACTG A5117 Study Group. HIV neuropathy natural history cohort study: assessment measures and risk factors. Neurology. 2006 Jun 13;66(11):1679-87.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
July 2004
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Inclusion Criteria

Control volunteers will be eligible for this study if they:

  • Are HIV negative.
  • Are at least 18 years old.

Patients will be eligible for this study if they:

  • Are HIV positive.
  • Are at least 13 years old and can provide written consent from parent or guardian if under 18 years of age.
  • Have taken anti-HIV drugs for at least 15 straight weeks any time in the past.
  • Have a CD4 count of less than 300 cells/mm3.

Exclusion Criteria

Control volunteers will not be eligible for this study if they:

  • Have any nerve-related problems.
  • Have diabetes and nerve damage related to diabetes.
  • Have long-term illness the doctor feels would interfere with the study.

Patients will not be eligible for this study if they:

  • Have had spinal surgery.
  • Have taken insulin or oral hypoglycemic products for diabetes mellitus within 30 days prior to study entry. Dietary control for diabetes is allowed.
  • Have nerve damage related to diabetes.
  • Have a nerve condition unrelated to HIV infection or antiretroviral therapy.
  • Have alcohol-related medical complications within 6 months of study entry.
  • Have vitamin B12 levels of less than 200 pg/ml or a history of vitamin B12 deficiency.

This study has been changed to modify the exclusion criteria. Earlier versions did not include some of these exclusion criteria.

Both
13 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00017771
A5117, AACTG A5117, ACTG A5117, 10935
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National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: David Simpson
National Institute of Allergy and Infectious Diseases (NIAID)
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP