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
4 other identifiers
observational
100
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2001
Typical duration for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2001
CompletedFirst Submitted
Initial submission to the registry
June 11, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2004
CompletedJuly 29, 2013
July 1, 2013
June 11, 2001
July 26, 2013
Conditions
Keywords
Eligibility Criteria
HIV-infected individuals who have previously undergone HIV treatment. HIV-uninfected to be used as controls.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
UCLA CARE Ctr
Los Angeles, California, 90095, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Univ of Hawaii
Honolulu, Hawaii, 96816, United States
The CORE Ctr
Chicago, Illinois, 60612, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202, United States
Wishard Hosp
Indianapolis, Indiana, 46202, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Washington Univ / St Louis Connect Care
St Louis, Missouri, 63108, United States
Washington Univ School of Medicine
St Louis, Missouri, 63108, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Mount Sinai Med Ctr
Pittsburgh, Pennsylvania, 15213, United States
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, 75390, United States
Univ of Washington
Seattle, Washington, 98104, United States
Related Publications (2)
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. doi: 10.1212/01.wnl.0000218303.48113.5d.
PMID: 16769940RESULTRoda RH, Bargiela D, Chen W, Perry K, Ellis RJ, Clifford DB, Bharti A, Kallianpur AR, Oliveira MF, Diaz MM, Rubin LH, Gavegnano C, McArthur JC, Hoke A, Polydefkis M. Large Mitochondrial DNA Deletions in HIV Sensory Neuropathy. Neurology. 2021 Jul 13;97(2):e156-e165. doi: 10.1212/WNL.0000000000012142. Epub 2021 May 4.
PMID: 33947785DERIVED
Biospecimen
Blood collection
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
David Simpson
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2001
First Posted
August 31, 2001
Study Start
June 1, 2001
Study Completion
July 1, 2004
Last Updated
July 29, 2013
Record last verified: 2013-07