Acetyl-L-Carnitine for the Treatment of NRTI-Associated Peripheral Neuropathy
NCT ID: NCT00050271
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2007-01-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Acetyl-L-carnitine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 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.
13 Years
ALL
No
Sponsors
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Neurologic AIDS Research Consortium (NARC)
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Victor Valcour, M.D.
Role: STUDY_CHAIR
University of Hawaii
Russell Bartt, M.D.
Role: STUDY_CHAIR
Cook County Hospital and Rush-Presbyterian St. Luke's Medical Center
Locations
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Stanford CRS
Palo Alto, California, United States
The Ponce de Leon Ctr. CRS
Atlanta, Georgia, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States
Northwestern University CRS
Chicago, Illinois, United States
Cook County Hosp. CORE Ctr.
Chicago, Illinois, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States
Washington U CRS
St Louis, Missouri, United States
Beth Israel Med. Ctr., ACTU
New York, New York, United States
Weill Med. College of Cornell Univ., The Cornell CTU
New York, New York, United States
University of Washington AIDS CRS
Seattle, Washington, United States
Puerto Rico-AIDS CRS
San Juan, , Puerto Rico
Countries
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References
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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.
Simpson 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.
Polydefkis 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.
Scarpini 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.
Other Identifiers
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10004
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG A5157
Identifier Type: -
Identifier Source: secondary_id
A5157
Identifier Type: -
Identifier Source: org_study_id