CLINICAL TRIAL: TRIAL OF URIDINE SUPPLEMENTATION IN 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 NucleomaxXfor 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 (Zerit¿) or zidovudine (Retrovir¿). The study will also assess the safety and tolerability of NucleomaxX in this population. This study will try to see if taking uridine is safe in HIV-infected persons and if it will reverse loss of fat in the face, arms, legs, or buttocks. The study will also try to see how well uridine is tolerated. Uridine is a powdered nutritional food supplement that contains a substance called uridine. It comes in a sachet (packet) and needs to be mixed in with juice, milk, or water. Uridine is used in Europe as a food supplement but is not approved by the U.S. Food and Drug Administration (FDA) and is considered an experimental drug in the U.S.