February 1, 2009

Acetyl-L-Carnitine and NRTI-associated neuropathy in HIV-infection

Victor Valcoura, Tzu-min Yeh, Russell Bartt, David Clifford, Mariana Gerschenson, Scott R. Evans, Bruce A Cohen, Gigi J. Ebenezer, Peter Hauer, Linda Millar, Mary Gould, Paul Tran , Cecilia Shikuma, Scott Souza, Justin C. McArthur, and the AIDS Clinical Trails Group (ACTG) 5157 protocol team

HIV Medicine

Objectives—Antiretroviral Toxic Neuropathy is associated with dideoxy-nucleoside reverse transcriptase inhibitor use in HIV, possibly due to mitochondrial toxicity. Acetyl-L-Carnitine (ALC) has been linked to symptomatic improvement in ATN. We present an open-label single-arm pilot study to evaluate change in intra-epidermal nerve fiber (IENF) density and mitochondrial DNA (mtDNA) copies/cell among subjects treated with 3000mg ALC daily.

Methods—Punch skin biopsies were examined at baseline and 24 weeks after therapy. Participants reported neuropathic symptoms using the Gracely Pain Intensity Score. Neurological examinations were completed.

Results—Twenty-one subjects completed the study. ALC was generally well-tolerated. The IENF density did not change among cases completing 24 weeks of ALC therapy, with median (90% confidence interval (CI)) IENF changes of −1.70 (−3.50, ∞), p=0.98 and 2.15 (−0.10, ∞), p=0.11 for the distal leg and proximal thigh, respectively. Fat mtDNA copies/cell did not change with therapy. Improvements in neuropathic pain (p<0.01), paresthesias (p=0.01), and symptoms of numbness (p<0.01) were noted. Similarly, improvement was noted on the Gracely Pain Intensity Scores.

Conclusions—ALC therapy coincided with improvements in subjective measures of pain in this open-label single-arm study. However, changes were not observed in objective measures of IENF density or mtDNA levels, providing little objective support for use of ALC in this setting.

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