A prospective, double blind, randomised, placebo controlled trial evaluating Acetyl-L-Carnitine (ALCAR) for the prevention of distal symmetric polyneuropathy in HIV infected individuals

Background: Nucleoside reverse transcriptase inhibitors (NRTIs) are currently an essential part of highly active antiretroviral therapy (HAART) for the treatment of HIV. However, the use of some dideoxynucleotide analogues may be limited by mitochondrial toxicity leading to distal symmetric polyneuropathy (DSP). Acetyl-L-Carnitine (ALCAR) has been investigated for the treatment of existing DSP but the potential for ALCAR to prevent DSP is unknown. Methods: In this double blind, placebo controlled trial 43 HIV infected, antiretroviral naïve individuals were randomised to receive either ALCAR or placebo in addition to stavudine (as stavudine-XR, a sustained release formulation), tenofovir and efavirenz for 48 weeks. Development of DSP was assessed clinically and histologically by Protein Gene Product (PGP) staining of the epidermis. Quality of life (QOL) was measured during the study with the MOS-HIV Health Survey and the QUROQOL Score questionnaires. Results: Twenty one subjects in each treatment arm were followed through 48 weeks. Discontinuation rates for stavudine and ALCAR versus placebo were similar in both groups. No differences were found for histological examination or clinical assessment of DSP; whilst the safety profile of ALCAR was comparable to placebo. Conclusions: At 48 weeks the prophylactic administration of ALCAR with HAART to prevent DSP was no different than placebo, with a similar safety profile. © 2010 Mentzer A, et al.