HIV InfectionsNCT00050271
Acetyl-L-Carnitine for the Treatment of NRTI-Associated Peripheral Neuropathy
A study testing Acetyl-L-carnitine in people with HIV Infections and Peripheral Nervous System Diseases, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in 2 countries.
Trial summary
The purpose of this study is to determine if acetyl-L-carnitine (ALC) reduces pain, numbness, and tingling in the feet and legs of patients with nucleoside reverse transcriptase inhibitor (NRTI)-associated peripheral neuropathy. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections, Peripheral Nervous System Diseases
- What is being tested?
- Acetyl-L-carnitine
- How many people
- 27 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Start not givento Jan 2007
- Phase
- Interventional
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HIV-1 infection
- Viral load <= 10,000 copies/ml within 60 days of entry
- On stable antiretroviral medication for 8 weeks prior to entry and plan on staying on current regimen for the duration of the study
- Currently taking at least one dideoxynucleoside analogue. Patients discontinuing their dideoxynucleoside analogues or changing their antiretroviral regimen after entry will remain on study drug and continue with the study requirements and evaluation visits.
- No significant systemic antiretroviral toxicity
- Evidence of predominantly sensory neuropathy, as determined from an examination by a neurologist
Show all 9Show fewer
- Ongoing neuropathy of any duration
- Negative pregnancy test performed at screening and within 24 hours of study entry
- Agree not to become pregnant or to impregnate; agree to use acceptable methods of contraception
Who cannot join
- ALC or similar drug within 90 days of entry
- Active AIDS-defining opportunistic infection (OI) or OI-defining condition within 30 days prior to entry
- Any condition or history of any condition, other than that related to HIV infection or antiretroviral therapy, that would add confusion to the diagnosis of dideoxynucleoside analogue-associated DSPN
- Pregnancy or breast-feeding
- Active malignancy
- Seizure disorder or history of seizure within 90 days of entry
Show all 13Show fewer
- Current or history of bipolar disorder
- Certain drugs within 30 days of study entry
- Addition of certain pain medication during the 60 days prior to study entry
- Allergy/sensitivity to study drug or its formulations
- Any condition that, in the opinion of the site investigator, would interfere with the study requirements
- Myelopathy
- Use of investigational agents that are not FDA-approved within 30 days of study entry, except when approved by the study chair. Investigational antiretroviral drugs available through expanded access or through AACTG trials will be allowed if they do not conflict with study criteria.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
The Ponce de Leon Ctr. CRS
Atlanta, Georgia, 30308
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287-8106
Northwestern University CRS
Chicago, Illinois, 60611-3015
Cook County Hosp. CORE Ctr.
Chicago, Illinois, 60612
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii
Beth Israel Med. Ctr., ACTU
New York, New York, 10003
Weill Med. College of Cornell Univ., The Cornell CTU
New York, New York
Stanford CRS
Palo Alto, California, 94305
University of Washington AIDS CRS
Seattle, Washington, 90033-1079
Washington U CRS
St Louis, Missouri, 63108-2138
About this study
Official title: An Open-Label, Dose-Escalation Pilot Study of Acetyl-L-Carnitine for the Treatment of Dideoxynucleoside-Associated Distal Symmetric Peripheral Neuropathy
The purpose of this study is to determine if acetyl-L-carnitine (ALC) reduces pain, numbness, and tingling in the feet and legs of patients with nucleoside reverse transcriptase inhibitor (NRTI)-associated peripheral neuropathy. Another purpose is to determine if ALC is safe and tolerable in HIV patients who have taken certain anti-HIV drugs.
Read the detailed description
Distal symmetric peripheral neuropathy (DSPN) is the most frequent neurologic complication of HIV infection and its treatments. NRTIs, particularly dideoxy-NRTIs, represent a significant risk factor for developing neuropathy. To date, there are no effective treatments for DSPN. Studies of nonneuronal tissues indicate a beneficial effect of ALC in HIV-1 seropositive individuals, but the role of ALC levels in patients with DSPN is unclear. Despite conflicting data, carnitine and its derivatives are still commonly used.
Patients will have a screening visit and visits at entry and Weeks 6, 12, 18, and 24. Patients are required to fast (no food or drink except water) for 4-12 hours for the screening visit, entry visit, and at Weeks 12 and 24. Targeted physical examinations, blood chemistries, liver function tests, HIV-1 RNA, CD4/CD8 cell counts, hematology, and lactate assessments will be done. Patients will also have a small skin biopsy at entry and Week 24. Patients will begin with 1 tablet of ALC twice daily and escalate dosage to a target dose of 3 tablets daily. They will remain on the 3-tablet dose or a maximum tolerated dose for the duration of the study (24 weeks).
- Conditions
- HIV Infections, Peripheral Nervous System Diseases
- Being tested
- Acetyl-L-carnitine
- Keywords
- Acetylcarnitine, Dideoxynucleosides, Epidermis, Biopsy, Immunohistochemistry, Nerve Fibers, Treatment Experienced
- Medical subject headings
- HIV Infections, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetyl-L-carnitineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2002 (estimated)
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Neurologic AIDS Research Consortium (NARC)
- Responsible party
- Sponsor
- Investigators
- Victor Valcour, M.D., Study chair, University of HawaiiRussell Bartt, M.D., Study chair, Cook County Hospital and Rush-Presbyterian St. Luke's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050271
- Sponsor's protocol ID
- A5157
- Other IDs
- 10004, ACTG A5157
- Status last verified
- Oct 2021
- First submitted
- 3 Dec 2002
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
Wulff EA, Wang AK, Simpson DM. HIV-associated peripheral neuropathy: epidemiology, pathophysiology and treatment. Drugs. 2000 Jun;59(6):1251-60. doi: 10.2165/00003495-200059060-00005.
PubMed 10882161Simpson DM, Katzenstein D, Haidich B, Millington D, Yiannoutsos C, Schifitto G, McArthur J; AIDS Clinical Trials Group Protocol 291/860 Study Team. Plasma carnitine in HIV-associated neuropathy. AIDS. 2001 Nov 9;15(16):2207-8. doi: 10.1097/00002030-200111090-00025. No abstract available.
PubMed 11684949Polydefkis M, Yiannoutsos CT, Cohen BA, Hollander H, Schifitto G, Clifford DB, Simpson DM, Katzenstein D, Shriver S, Hauer P, Brown A, Haidich AB, Moo L, McArthur JC. Reduced intraepidermal nerve fiber density in HIV-associated sensory neuropathy. Neurology. 2002 Jan 8;58(1):115-9. doi: 10.1212/wnl.58.1.115.
PubMed 11781415Scarpini E, Sacilotto G, Baron P, Cusini M, Scarlato G. Effect of acetyl-L-carnitine in the treatment of painful peripheral neuropathies in HIV+ patients. J Peripher Nerv Syst. 1997;2(3):250-2.
PubMed 10975731
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose-Escalation Pilot Study of Acetyl-L-Carnitine for the Treatment of Dideoxynucleoside-Associated Distal Symmetric Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT00050271
- Acronym / sponsor ID
- A5157
- Conditions
- HIV Infections, Peripheral Nervous System Diseases
- Keywords
- Acetylcarnitine, Dideoxynucleosides, Epidermis, Biopsy, Immunohistochemistry, Nerve Fibers, Treatment Experienced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Neurologic AIDS Research Consortium (NARC)
- Study completion
- Jan 2007 (actual)
- First posted
- 4 Dec 2002 (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 determine if acetyl-L-carnitine (ALC) reduces pain, numbness, and tingling in the feet and legs of patients with nucleoside reverse transcriptase inhibitor (NRTI)-associated peripheral neuropathy. Another purpose is to determine if ALC is safe and tolerable in HIV patients who have taken certain anti-HIV drugs.
Detailed description
Distal symmetric peripheral neuropathy (DSPN) is the most frequent neurologic complication of HIV infection and its treatments. NRTIs, particularly dideoxy-NRTIs, represent a significant risk factor for developing neuropathy. To date, there are no effective treatments for DSPN. Studies of nonneuronal tissues indicate a beneficial effect of ALC in HIV-1 seropositive individuals, but the role of ALC levels in patients with DSPN is unclear. Despite conflicting data, carnitine and its derivatives are still commonly used.
Patients will have a screening visit and visits at entry and Weeks 6, 12, 18, and 24. Patients are required to fast (no food or drink except water) for 4-12 hours for the screening visit, entry visit, and at Weeks 12 and 24. Targeted physical examinations, blood chemistries, liver function tests, HIV-1 RNA, CD4/CD8 cell counts, hematology, and lactate assessments will be done. Patients will also have a small skin biopsy at entry and Week 24. Patients will begin with 1 tablet of ALC twice daily and escalate dosage to a target dose of 3 tablets daily. They will remain on the 3-tablet dose or a maximum tolerated dose for the duration of the study (24 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- HIV-1 infection
- Viral load <= 10,000 copies/ml within 60 days of entry
- On stable antiretroviral medication for 8 weeks prior to entry and plan on staying on current regimen for the duration of the study
- Currently taking at least one dideoxynucleoside analogue. Patients discontinuing their dideoxynucleoside analogues or changing their antiretroviral regimen after entry will remain on study drug and continue with the study requirements and evaluation visits.
- No significant systemic antiretroviral toxicity
Key exclusion criteria (13 listed)
- ALC or similar drug within 90 days of entry
- Active AIDS-defining opportunistic infection (OI) or OI-defining condition within 30 days prior to entry
- Any condition or history of any condition, other than that related to HIV infection or antiretroviral therapy, that would add confusion to the diagnosis of dideoxynucleoside analogue-associated DSPN
- Pregnancy or breast-feeding
- Active malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetyl-L-carnitine | Drug | – |
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 1 Nov 2021.
- Background: PubMed 10882161Wulff EA, Wang AK, Simpson DM. HIV-associated peripheral neuropathy: epidemiology, pathophysiology and treatment. Drugs. 2000 Jun;59(6):1251-60. doi: 10.2165/00003495-200059060-00005.
- Background: PubMed 11684949Simpson DM, Katzenstein D, Haidich B, Millington D, Yiannoutsos C, Schifitto G, McArthur J; AIDS Clinical Trials Group Protocol 291/860 Study Team. Plasma carnitine in HIV-associated neuropathy. AIDS. 2001 Nov 9;15(16):2207-8. doi: 10.1097/00002030-200111090-00025. No abstract available.
- Background: PubMed 11781415Polydefkis M, Yiannoutsos CT, Cohen BA, Hollander H, Schifitto G, Clifford DB, Simpson DM, Katzenstein D, Shriver S, Hauer P, Brown A, Haidich AB, Moo L, McArthur JC. Reduced intraepidermal nerve fiber density in HIV-associated sensory neuropathy. Neurology. 2002 Jan 8;58(1):115-9. doi: 10.1212/wnl.58.1.115.
- Background: PubMed 10975731Scarpini E, Sacilotto G, Baron P, Cusini M, Scarlato G. Effect of acetyl-L-carnitine in the treatment of painful peripheral neuropathies in HIV+ patients. J Peripher Nerv Syst. 1997;2(3):250-2.
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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.
Victor Valcour, M.D. study chair
University of Hawaii
Russell Bartt, M.D. study chair
Cook County Hospital and Rush-Presbyterian St. Luke's Medical Center
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetyl-L-carnitine in people with HIV Infections and Peripheral Nervous System Diseases, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in 2 countries.
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 9 inclusion and 13 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Puerto Rico. 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 NCT00050271, which also lists 4 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 1 Nov 2021.