This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor 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.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000037-47
Application #
7603504
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2007-04-01
Project End
2007-09-16
Budget Start
2007-04-01
Budget End
2007-09-16
Support Year
47
Fiscal Year
2007
Total Cost
$490
Indirect Cost
Name
University of Washington
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
605799469
City
Seattle
State
WA
Country
United States
Zip Code
98195
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