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

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Neurologic AIDS Research Consortium (NARC)
• Treatments: Acetylcarnitine; Dideoxynucleosides

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.