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)

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)

Author Cahn, P. Google Scholar
Ruxrungtham, K. Google Scholar
Gazzard, B. Google Scholar
Diaz, Ricardo Sobhie Autor UNIFESP Google Scholar
Gori, A. Google Scholar
Kotler, D. P. Google Scholar
Vriesema, A. Google Scholar
Georgiou, N. A. Google Scholar
Garssen, J. Google Scholar
Clerici, M. Google Scholar
Lange, J. M. A. Google Scholar
BITE Blinded Nutr Study Immunity Google Scholar
Institution Fdn Huesped
Chulalongkorn Univ
Chelsea & Westminster Hosp NHS Fdn Trust
Universidade Federal de São Paulo (UNIFESP)
Univ Milan
St Lukes Roosevelt Hosp
Ctr Specialised Nutr
Univ Utrecht
Univ Amsterdam
Abstract 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/mu L, 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/mu L difference (P =.03) in the intention-to-treat population in favor of the immunomodulatory NR100157 (control vs active, -68 +/- 15 vs -28 +/- 16 cells/mu L/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 HIV1-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.)
Keywords immunonutrition
NR100157
immune activation
CD4 decline
Language English
Sponsor Nutricia Advanced Medical Nutrition, Danone Research Centre for Specialised Nutrition, Wageningen, the Netherlands
Date 2013-07-01
Published in Clinical Infectious Diseases. Cary: Oxford Univ Press Inc, v. 57, n. 1, p. 139-146, 2013.
ISSN 1058-4838 (Sherpa/Romeo, impact factor)
Publisher Oxford Univ Press Inc
Extent 139-146
Origin http://dx.doi.org/10.1093/cid/cit171
Access rights Open access Open Access
Type Article
Web of Science ID WOS:000320923700020
URI http://repositorio.unifesp.br/handle/11600/36450

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