This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. DESIGN: A multicenter, open-label, 24-week pilot study with dose escalation of acetyl-L-carnitine (ALC) for the treatment of distal symmetric peripheral neuropathy (DSPN) associated with dideoxynucleosides in HIV-infected subjects. Gracely pain scale assessments and safety information will be obtained every 6 weeks. An intraepidermal nerve-fiber and subcutaneous adipose tissue biopsy will be obtained at baseline and 24 weeks. DURATION: 24 weeks SAMPLE SIZE: 36 subjects POPULATION: HIV-1-infected subjects with dideoxynucleoside-associated DSPN. The appearance or worsening of the neuropathic symptoms must be associated with (have occurred within 12 months of) the initiation of one or more dideoxynucleoside analogues or with a dose-escalation of one or more of the dideoxynucleoside analogues. In the opinion of the site neurologist, the appearance or worsening of neuropathy must be attributable, at least in part, to dideoxynucleoside use. REGIMEN: Subjects will begin with ALC 500 mg twice daily and escalate dosage to a target dose of 1500 mg twice daily. Subjects will remain on the 1500-mg dose or a maximum tolerated dose for the duration of the study (24 weeks, which includes the 3-week dose-escalation phase).
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