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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050271
• Other study ID #: A5157
• Secondary ID: 10004ACTG A5157
• Status: Completed
• Phase: N/A
• Est. completion date: January 2007

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Another purpose is to determine if ALC is safe and tolerable in HIV patients who have taken certain anti-HIV drugs.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Nervous System Diseases
• Peripheral Nervous System Diseases

Intervention

Drug:
• Acetyl-L-carnitine

Locations

Country	Name	City	State
Puerto Rico	Puerto Rico-AIDS CRS	San Juan
United States	The Ponce de Leon Ctr. CRS	Atlanta	Georgia
United States	Johns Hopkins Adult AIDS CRS	Baltimore	Maryland
United States	Cook County Hosp. CORE Ctr.	Chicago	Illinois
United States	Northwestern University CRS	Chicago	Illinois
United States	Univ. of Hawaii at Manoa, Leahi Hosp.	Honolulu	Hawaii
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	Stanford CRS	Palo Alto	California
United States	Washington U CRS	Saint Louis	Missouri
United States	University of Washington AIDS CRS	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Neurologic AIDS Research Consortium (NARC)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (4)

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. — View 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. — View Citation

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. — View Citation

Wulff EA, Wang AK, Simpson DM. HIV-associated peripheral neuropathy: epidemiology, pathophysiology and treatment. Drugs. 2000 Jun;59(6):1251-60. Review. — View Citation

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