HIV InfectionsNCT00017771
Nerve Damage in Patients With HIV Infection Who Have Been Treated With Anti-HIV Drugs
An observational study of HIV Infections and Peripheral Nervous System Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Peripheral Nervous System Disease
- How many people
- 100 participants
- Where
- 18 sitesUnited States
- Study dates
- Jun 2001to Jul 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: HIV-infected individuals who have previously undergone HIV treatment. HIV-uninfected to be used as controls.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Johns Hopkins Hosp
Baltimore, Maryland, 21287
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
The CORE Ctr
Chicago, Illinois, 60612
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, 75390
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
Univ of Hawaii
Honolulu, Hawaii, 96816
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
Wishard Hosp
Indianapolis, Indiana, 46202
UCLA CARE Ctr
Los Angeles, California, 90095
Beth Israel Med Ctr
New York, New York, 10003
Cornell Univ Med Ctr
New York, New York, 10021
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mount Sinai Med Ctr
Pittsburgh, Pennsylvania, 15213
Univ of Rochester Medical Center
Rochester, New York, 14642
Univ of Washington
Seattle, Washington, 98104
Washington Univ / St Louis Connect Care
St Louis, Missouri, 63108
Washington Univ School of Medicine
St Louis, Missouri, 63108
About this study
Official title: 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.
Read the 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 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.
- Conditions
- HIV Infections, Peripheral Nervous System Disease
- Keywords
- HIV-1, CD4 Lymphocyte Count, Risk Factors, Hydroxyurea, Disease Progression, Alcohol Drinking, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, Polyneuropathies, Treatment Experienced
- Medical subject headings
- HIV Infections, Peripheral Nervous System Diseases, Disease Progression, Alcohol Drinking, Polyneuropathies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startJun 2001
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David Simpson, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00017771
- Sponsor's protocol ID
- A5117
- Other IDs
- AACTG A5117, ACTG A5117, 10935
- Status last verified
- Jul 2013
- First submitted
- 11 Jun 2001
- Last updated
- 29 Jul 2013
- Results posted
- No
Publications
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.
PubMed 16769940Roda 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.
PubMed 33947785
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pathophysiologic Study of Development of Distal Symmetrical Polyneuropathy in Individuals With Advanced HIV-1 Infection and Prior Antiretroviral Exposure
- ClinicalTrials.gov ID
- NCT00017771
- Acronym / sponsor ID
- A5117
- Conditions
- HIV Infections, Peripheral Nervous System Disease
- Keywords
- HIV-1, CD4 Lymphocyte Count, Risk Factors, Hydroxyurea, Disease Progression, Alcohol Drinking, Reverse Transcriptase Inhibitors, Anti-HIV Agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jun 2001
- Study completion
- Jul 2004 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HIV-infected individuals who have previously undergone HIV treatment. HIV-uninfected to be used as controls.
Key inclusion criteria (8 listed)
- Are HIV negative.
- Are at least 18 years old.
- 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.
Key exclusion criteria (12 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2013.
- Results publication: PubMed 16769940Simpson 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.
- Derived from this study: PubMed 33947785Roda 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Simpson study chair
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Peripheral Nervous System Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00017771, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2013.