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)

P. Cahn, K. Ruxrungtham, B. Gazzard, R. S. Diaz, A. Gori, D. P. Kotler, A. Vriesema, N. A. Georgiou, J. Garssen, M. Clerici, J. M A Lange

Research output: Contribution to journalArticle

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 + 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 + T-cell count (r =-0.55, P +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.

Original languageEnglish
Pages (from-to)139-146
Number of pages8
JournalClinical Infectious Diseases
Volume57
Issue number1
DOIs
Publication statusPublished - Jul 2013

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HIV
T-Lymphocytes
Viral Load
HIV-1
Cell Count
Lymphoid Tissue
Therapeutics
CD4 Lymphocyte Count
Gastrointestinal Tract
Homeostasis
Clinical Trials
Safety
Population

Keywords

  • CD4 decline
  • immune activation
  • immunonutrition
  • NR100157

ASJC Scopus subject areas

  • Infectious Diseases
  • Microbiology (medical)

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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). / 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.

In: Clinical Infectious Diseases, Vol. 57, No. 1, 07.2013, p. 139-146.

Research output: Contribution to journalArticle

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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 + 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 + T-cell count (r =-0.55, P +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.",
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AU - Ruxrungtham, K.

AU - Gazzard, B.

AU - Diaz, R. S.

AU - Gori, A.

AU - Kotler, D. P.

AU - Vriesema, A.

AU - Georgiou, N. A.

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AU - Lange, J. M A

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AB - 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 + 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 + T-cell count (r =-0.55, P +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.

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