The immunomodulatory nutritional intervention NR100157 reduced CD4 + T-cell decline and immune activation: A 1-year multicenter randomized controlled double-blind trial in HIV-infected persons not receiving antiretroviral therapy (The BITE Study)

Background The immunomodulatory nutritional product NR100157 was developed for human immunodeficiency virus (HIV)-infected individuals. We hypothesized that targeting the compromised gastrointestinal tract of HIV-infected individuals would result in systemic immunological benefits.Methods In a multicenter, randomized, controlled, double-blind trial, 340 HIV-1-positive adults not on antiretroviral therapy, with CD4+ T-cell counts <800/μL, were given either NR100157 or an isocaloric and isonitrogenous control for 52 weeks. Primary outcome was CD4+ T-cell count. Secondary outcomes included plasma viral load (pVL), safety, and tolerability. In a pilot study (n = 20), levels of CD4+CD25+ and CD8+CD38+ activation were measured (n = 20). The trial is registered at the Dutch Trial Register (NTR886) and ISRCTN81868024.Results At 52 weeks, CD4+ T-cell decline showed a 40-cell/μL difference (P =. 03) in the intention-to-treat population in favor of the immunomodulatory NR100157 (control vs active,-68 ± 15 vs-28 ± 16 cells/μL/year). The change in pVL from baseline was similar between groups (P =. 81). In the pilot study, the percentage of CD4+CD25+ was lower in the active group (P <. 05) and correlated with changes in CD4+ T-cell count (r =-0.55, P <. 05). The percentage of CD8+CD38+ levels was unaffected.Conclusions The specific immunonutritional product NR100157 significantly reduces CD4+ decline in HIV-1-infected individuals, and this is associated with decreased levels of CD4 +CD25+. (This nutritional intervention is likely to affect local gut integrity and gut-associated lymphoid tissue homeostasis, which in turn translates positively to systemic effects.)Clinical Trials Registration.ISRCTN81868024. © 2013 The Author.