title: Uridine supplementation in HIV lipoatrophy: pilot trial on safety and effect on mitochondrial indices.
abstract: OBJECTIVE
  Uridine abrogates mitochondrial toxicities of nucleoside reverse transcriptase inhibitor in adipocyte cell culture. We aim to study the effect of uridine supplementation on human adipocyte mitochondrial DNA (mtDNA) levels in subjects with human immunodeficiency (HIV) lipoatrophy.
  
  
  METHODS
  Sixteen patients with lipoatrophy on stavudine-containing antiretroviral therapy were enrolled, and received NucleomaxX, a dietary supplement with a high bioavailability of uridine (36 g TID every other day for 16 weeks). Patients were then followed off-uridine for another 16 weeks. Highly active antiretroviral therapy remained unchanged during the trial.
  
  
  RESULTS
  Fourteen patients completed the study. Two subjects dropped out before week 4 for study-unrelated reasons. No adverse events were noted throughout the study. HIV-1 RNA, CD4 counts, liver enzymes and hemoglobin remained unchanged. Body mass index, lactate, lipids, insulin and homeostasis model assessment of insulin resistance were unaltered. Fat and peripheral blood and mononuclear cell mtDNA levels did not correlate with each other and exhibited no changes throughout the study. Lipoatrophy scores by patients and physician improved significantly at weeks 16 and 32 compared to study entry.
  
  
  CONCLUSIONS
  In this pilot study, NucleomaxX was safe, well tolerated without apparent deleterious effect on HIV indices. In contrast to in vitro data, NucleomaxX did not lead to changes in fat or blood mtDNA levels.
authors.affiliation: Department of Pediatrics, Rainbow Babies and Children's Hospital, Cleveland, OH 44106, USA. mccomsey.grace@clevelandactu.org
authors.forename: G A
authors.initials: GA
authors.lastname: McComsey
authors.forename: M
authors.initials: M
authors.lastname: O'Riordan
authors.forename: B
authors.initials: B
authors.lastname: Setzer
authors.forename: D
authors.initials: D
authors.lastname: Lebrecht
authors.forename: E
authors.initials: E
authors.lastname: Baron
authors.forename: U A
authors.initials: UA
authors.lastname: Walker
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000009:adverse effects; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects*; D001823:Body Composition / Q000187:drug effects; D050218:Body Fat Distribution; D004272:DNA, Mitochondrial / Q000187:drug effects*; D019587:Dietary Supplements; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy / Q000821:virology; D039682:HIV-Associated Lipodystrophy Syndrome / Q000139:chemically induced* / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012449:Safety; D050151:Subcutaneous Fat / Q000187:drug effects; D016896:Treatment Outcome; D014529:Uridine / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D044966:Anti-Retroviral Agents; D004272:DNA, Mitochondrial; D014529:Uridine