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 language | English |
|---|---|
| Pages (from-to) | 139-146 |
| Number of pages | 8 |
| Journal | Clinical Infectious Diseases |
| Volume | 57 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Jul 2013 |
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Keywords
- CD4 decline
- immune activation
- immunonutrition
- NR100157
ASJC Scopus subject areas
- Infectious Diseases
- Microbiology (medical)
Cite this
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 journal › Article
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TY - JOUR
T1 - The immunomodulatory nutritional intervention NR100157 reduced CD4 + T-cell decline and immune activation
T2 - A 1-year multicenter randomized controlled double-blind trial in HIV-infected persons not receiving antiretroviral therapy (The BITE Study)
AU - Cahn, P.
AU - Ruxrungtham, K.
AU - Gazzard, B.
AU - Diaz, R. S.
AU - Gori, A.
AU - Kotler, D. P.
AU - Vriesema, A.
AU - Georgiou, N. A.
AU - Garssen, J.
AU - Clerici, M.
AU - Lange, J. M A
PY - 2013/7
Y1 - 2013/7
N2 - 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.
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.
KW - CD4 decline
KW - immune activation
KW - immunonutrition
KW - NR100157
UR - http://www.scopus.com/inward/record.url?scp=84878875269&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84878875269&partnerID=8YFLogxK
U2 - 10.1093/cid/cit171
DO - 10.1093/cid/cit171
M3 - Article
C2 - 23511299
AN - SCOPUS:84878875269
VL - 57
SP - 139
EP - 146
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
SN - 1058-4838
IS - 1
ER -