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- Title
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).
- Authors
Cahn, P.; Ruxrungtham, K.; Gazzard, B.; Diaz, R.S.; Gori, A.; Kotler, D.P.; Vriesema, A.; Georgiou, N. A.; Garssen, J.; Clerici, M.; Lange, J. M. A.
- Abstract
A 52-week supplementation with the immunomodulatory nutritional product NR100157 resulted in a beneficial 40-cell/µL difference in human immunodeficiency virus–infected patients not on antiretroviral therapy. In a pilot study, reduced CD4+CD25+ activation was observed. This inversely correlated with CD4+ T-cell count.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.
- Subjects
IMMUNOREGULATION; CELLULAR immunity; RANDOMIZED controlled trials; HIV-positive persons; HIGHLY active antiretroviral therapy; CELL differentiation
- Publication
Clinical Infectious Diseases, 2013, Vol 57, Issue 1, p139
- ISSN
1058-4838
- Publication type
Article