URIDINE SUPPLEMENTATION FOR TREATMENT OF HIV LIPOATROPHY

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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. A5229 is a phase II/III, randomized, double blind, placebo-controlled study of uridine supplementation in the form of NucleomaxX for treatment of HIV-associated lipoatrophy. NucleomaxX is a food supplement in Europe, which is considered an experimental drug in the U.S. A total of 164 subjects nationally (up to 10 locally) will be randomized to NucleomaxX or placebo for 48 weeks, and followed in a standardized fashion for efficacy and toxicity. This study will examine the effect of NucleomaxX at a dose of 36 grams (1 packet) 3 times a day every other day on limb fat measured by DEXA (dual-energy x-ray absorptiometry) in human immunodeficiency virus (HIV)-infected subjects receiving stable antiretroviral therapy containing stavudine (d4T) or zidovudine (ZDV) in combination with other antiretroviral drugs. The study also will assess the safety and tolerability of NucleomaxX. The DEXA scans will be done at the UW General Clinical Research Center, and all other study procedures will be done at the UW AIDS Clinical Trials Unit.