A PHASE II/III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIA

$9,080M01FY2009RRNIH

Lundquist Institute For Biomedical Innovation At Harbor-Ucla Medical Center, Torrance CA

Investigators

Linked publications, trials & patents

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Abstract

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. The management of HIV has been complicated by lipoatrophy, a distressing long-term complication of Antiretroviral treatment associated with decreased quality of life, disincentive for adherence to therapy, as well as possibly increased risk of cardiovascular disease. A proposed mechanism for the development of lipoatrophy is mitochondrial DNA-depletion in subcutaneous adipose tissue caused by thymidine analogue nucleoside analogues (zidovudine [ZDV] or stavudine [d4T]). Unfortunately, no therapy is available for clinical lipoatrophy. To date, several strategies have been unsuccessful in reversing this condition. The most successful intervention has been the replacement of d4T with abacavir. However, about 5% of people experience serious hypersensitivity reactions on abacavir. Recent studies have reported similar improvement in peripheral fat after replacement of d4T or ZDV with tenofovir. Additionally, many ART-experienced persons are not suitable candidates for this nucleoside substitution strategydue to underlying necleoside resistance. The purpose of this study is to see of taking a uridine supplement (NecleomaxX) is safe in HIV infected persons and if it will reverse loss of fat in the face, arms, legs, and buttocks.

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