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

Completed · Not applicable

Conditions studied: HIV Infections, Peripheral Nervous System Diseases

In brief

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.

Key facts

Study ID

NCT00050271

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

27

Expected to finish

2007-01-01

Last updated by the study team

2021-11-01

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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