Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017771
Status:
COMPLETED
Last Update Posted:
2013-07-29
First Post:
2001-06-11
Brief Title:
Nerve Damage in Patients With HIV Infection Who Have Been Treated With Anti-HIV Drugs
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Pathophysiologic Study of Development of Distal Symmetrical Polyneuropathy in Individuals With Advanced HIV-1 Infection and Prior Antiretroviral Exposure
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 030502 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 030502 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
HIV-infected patients are characterized for the presence or absence of neuropathy at AS PER AMENDMENT 030502 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 030502 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10935 | REGISTRY | DAIDS-ES | None |
| AACTG A5117 | None | None | None |
| ACTG A5117 | None | None | None |