ACTG A5229:TRIAL OF URIDINE SUPPLEMENTATION

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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. Subjects will receive blinded study treatment for 48 weeks. This study will examine the effect of NucleomaxX on limb fat in HIV-1-infected subjects receiving stable antiretroviral therapy containing d4T or ZDV. The study also will assess the safety and tolerability of NucleomaxX in this population. HIV-1-infected men and women ?18 years of age, with clinical lipoatrophy and a cumulative duration of thymidine NRTI (ZDV or d4T) treatment of at least 24 weeks prior to study entry may be enrolled in this study. Subjects must have a plasma HIV-1 RNA level of or equal to 5000 copies/mL, and be receiving stable thymidine analogue-containing antiretroviral regimen for a minimum of 12 consecutive weeks prior to study entry, with no plan at study entry to significantly alter ART for the duration of the study. Antiretroviral drugs will not be provided by the study. At study entry, 164 subjects will be randomized 1:1 to one of the following: Arm A: NucleomaxX: One sachet (36 grams) orally three times per day, every other day Arm B: Placebo for NucleomaxX: One sachet (36 grams) orally three times per day, every other day. This every other day dosing will continue through day 336 (48 weeks). If all three sachets are not taken in one day (first 24 hour period), the unused sachet(s) can be taken the next day (second 24 hour period). Unused sachets not taken within the 2-day period (48 hours) are considered missed doses and must be returned to the clinic at the next visit. The subject must not take more than three doses in any 24 hour period and must wait at least 4 hours between taking each dose.