Acetyl-L-Carnitine for the Treatment of NRTI-Associated Peripheral Neuropathy
An Open-Label, Dose-Escalation Pilot Study of Acetyl-L-Carnitine for the Treatment of Dideoxynucleoside-Associated Distal Symmetric Peripheral Neuropathy
3 other identifiers
interventional
27
2 countries
11
Brief 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. Another purpose is to determine if ALC is safe and tolerable in HIV patients who have taken certain anti-HIV drugs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv-infections
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2002
CompletedFirst Posted
Study publicly available on registry
December 4, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedNovember 1, 2021
October 1, 2021
December 3, 2002
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Stanford CRS
Palo Alto, California, 94305, United States
The Ponce de Leon Ctr. CRS
Atlanta, Georgia, 30308, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States
Northwestern University CRS
Chicago, Illinois, 60611-3015, United States
Cook County Hosp. CORE Ctr.
Chicago, Illinois, 60612, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287-8106, United States
Washington U CRS
St Louis, Missouri, 63108-2138, United States
Beth Israel Med. Ctr., ACTU
New York, New York, 10003, United States
Weill Med. College of Cornell Univ., The Cornell CTU
New York, New York, United States
University of Washington AIDS CRS
Seattle, Washington, 90033-1079, United States
Puerto Rico-AIDS CRS
San Juan, 00936-5067, Puerto Rico
Related Publications (4)
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.
PMID: 10882161BACKGROUNDSimpson 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.
PMID: 11684949BACKGROUNDPolydefkis 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.
PMID: 11781415BACKGROUNDScarpini 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.
PMID: 10975731BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Victor Valcour, M.D.
University of Hawaii
- STUDY CHAIR
Russell Bartt, M.D.
Cook County Hospital and Rush-Presbyterian St. Luke's Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2002
First Posted
December 4, 2002
Study Completion
January 1, 2007
Last Updated
November 1, 2021
Record last verified: 2021-10