Chicago, Illinois 60611

  • Peripheral Nervous System Diseases

Purpose:

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.


Study summary:

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).


Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - 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.


Study is Available At:


Original ID:

A5157


NCT ID:

NCT00050271


Secondary ID:

10004


Study Acronym:


Brief Title:

Acetyl-L-Carnitine for the Treatment of NRTI-Associated Peripheral Neuropathy


Official Title:

An Open-Label, Dose-Escalation Pilot Study of Acetyl-L-Carnitine for the Treatment of Dideoxynucleoside-Associated Distal Symmetric Peripheral Neuropathy


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

13 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Allergy and Infectious Diseases (NIAID)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

27


Enrollment Type:

Actual


Overall Contact Information

Official Name:Victor Valcour, M.D.
Study Chair
University of Hawaii

Study Dates

Completion Date:January 2007
Completion Type:Actual
Verification Date:May 2012
Last Changed Date:May 17, 2012
First Received Date:December 3, 2002

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Acetyl-L-carnitine

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Allergy and Infectious Diseases (NIAID)
Agency Class:Other
Agency Type:Collaborator
Agency Name:Neurologic AIDS Research Consortium (NARC)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Wulff EA, Wang AK, Simpson DM. HIV-associated peripheral neuropathy: epidemiology, pathophysiology and treatment. Drugs. 2000 Jun;59(6):1251-60. Review.
PMID:10882161
Reference Type:Reference
Citation:Simpson DM, Katzenstein D, Haidich B, Millington D, Yiannoutsos C, Schifitto G, McArthur J. Plasma carnitine in HIV-associated neuropathy. AIDS. 2001 Nov 9;15(16):2207-8. No abstract available.
PMID:11684949
Reference Type:Reference
Citation: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.
PMID:11781415
Reference Type:Reference
Citation: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.
PMID:10975731

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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