Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy

• Change in Limb Fat (g) From Baseline [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
  Limb fat was measured at baseline and visit week 48 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.
  
  

• Time to Safety Events (Signs/Symptoms or Laboratory Abnormalities) [ Time Frame: Through Week 48 ] [ Designated as safety issue: Yes ]
  Time to safety events (grade 3 [Severe] or 4 [life-threatening] sign/symptom or laboratory-based abnormality that is at least one grade higher than baseline) from study entry
  
  
• Number of Subjects Discontinuing Study Medication [ Time Frame: Through Week 48 ] [ Designated as safety issue: No ]
  Number of eligible subjects who discontinued study medication during the study period.
  
  
• Change in Limb Fat From Baseline (Week 24 - Baseline) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  Limb fat was measured at baseline and visit week 24 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 24 (week 24 - baseline) was estimated for the treatment groups.
  
  
• HIV-1 RNA Level [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
  
• Change in CD4+ Count From Baseline (Week 48 - Baseline) [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
  
• Change in Fasting Lactate From Baseline (Week 48 - Baseline) [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
  
• Change in Fasting Glucose From Baseline (Week 48 - Baseline) [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
  
• Change in Fasting Total Cholesterol From Baseline (Week 48 - Baseline) [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
  
• Change in Fasting High-density Lipoprotein (HDL) Cholesterol From Baseline (Week 48 - Baseline) [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
  
• Change in Fasting Non-HDL Cholesterol From Baseline (Week 48 - Baseline) [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
  
• Change in Fasting Low-density Lipoprotein (LDL) Cholesterol From Baseline (Week 48 - Baseline) [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
  
• Change in Fasting Triglycerides From Baseline (Week 48 - Baseline) [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
  
• Change in Hemoglobin From Baseline (Week 48 - Baseline) [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
  
• Change in Leukocytes From Baseline (Week 48 - Baseline) [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
  
• Change in Creatine Kinase From Baseline (Week 48 - Baseline) [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
  

Lipoatrophy is a distressing long-term complication of ART and is associated with decreased quality of life, an increased risk of cardiovascular disease, and nonadherence to ART. The cause of lipoatrophy in HIV-infected individuals receiving ART is not completely understood. However, past research suggests that mitochondrial toxicity in subcutaneous adipose tissue caused by thymidine analogue nucleoside analogues may be responsible for the development of lipoatrophy.

Uridine is a nucleoside that has been shown to be an effective supplement in treating individuals with mitochondrial toxicity. NucleomaxX is a food supplement that consists of mitocnol, a sugar cane extract that has a high content of nucleosides, including uridine. The purpose of this study was to evaluate the effects of uridine supplementation in the form of NucleomaxX on limb fat in HIV-infected individuals receiving stable ART containing stavudine (d4T) or zidovudine (ZDV). In addition, this study evaluated the safety and tolerability of NucleomaxX.

This study lasted for 48 weeks. Participants were randomly assigned to one of two treatment arms, stratified by d4T or ZDV use. Arm A participants received NucleomaxX for uridine, while Arm B participants received a placebo for NucleomaxX. Participants in both arms received their assigned intervention three times per day, every other day, for the duration of the study. There were 8 study visits over the 48-week study duration. Blood collection and a physical exam occurred at all study visits, and participants completed an adherence assessment at most visits. Participants underwent dual energy X-ray absorptiometry scans (DEXA) within 14 days prior to or following the screening visit and at other selected visits. Specific fasting tests for glucose and lipid levels occurred at selected visits. ART was not provided by this study.