Uridine supplementation via NucleomaxX, (Pharma Nord) leads to no sustained increase in limb fat in HIV patients on thymidine nucleoside reverse transcriptase inhibitors (NRTIs), researchers report in a September 7th on-line paper in AIDS.
Dr Grace A. McComsey told Reuters Health by email that this finding “is very unfortunate for tens of thousands of HIV patients who continue to live and suffer from the negative effects of lipoatrophy. We had hoped that NucleomaxX would offer a treatment for this condition… but this is not the case.”
Dr. McComsey of Case School of Medicine, Cleveland, Ohio, and colleagues note that laboratory and other studies of the approach looked promising. A small Finnish trial found that 3 months of NucleomaxX supplementation improved limb fat. It also increased visceral abdominal fat and decreased HDL-cholesterol.
In the current study, the researchers randomized 165 patients on thymidine NRTIs to receive NucleomaxX or placebo. These agents were in the form of a 36 g sachet which was mixed with milk, juice, or water and taken every second day.
Although only 1 active treatment and 2 placebo patients discontinued therapy because of toxicity (diarrhea), another 65 did so chiefly because of the bitter taste of the preparations.
Intention-to-treat analysis showed no between-group differences in limb fat at 24 weeks or at the end of the 48-week study period.
When analysis was restricted to the 59% of patients who completed the study, at 24 weeks the active treatment group showed a 3.4% gain compared to a 0.8% drop with placebo. However, at 48 weeks, the corresponding values were 1.8% and 3.8%. Analysis of findings in patients with at least 80% adherence led to similar results. There were no clinically meaningful changes in fasting lipid levels.
The investigators conclude that at best the “effect size was very modest and unlikely to be appreciated by the participants.”
Dr. McComsey added that “this is one of these instances where laboratory studies showed excellent promising results but did not translate to human studies. This is why it is crucial to always design large well-powered clinical trials to try new compounds and not just rely on laboratory data or small pilot studies.”