A PHASE II/III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF URIDINE

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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 the treatment of HIV-associated lipoatrophy. This study will examine the effect of NucleomaxX on limb fat in HIV-1 infected subjects receiving stable antiretroviral therapy (ART) containing stavudine (d4T) or zidovudine (ZDV). The study will also assess the safety and tolerability of NucleomaxX in this population. Nationally, 164 subjects (82 per arm) will be enrolled. Subjects will have nine study visits with 48 weeks of treatment. Subjects will undergo physical exams, blood sampling, dual-energy x-ray absorptiometry (DEXA) scans, body shape/body image and dietary assessments.