RESUMO
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.
Assuntos
Linfócitos T CD4-Positivos/imunologia , Dieta/métodos , Infecções por HIV/imunologia , Infecções por HIV/terapia , Fatores Imunológicos/uso terapêutico , Adulto , Contagem de Linfócito CD4 , Linfócitos T CD8-Positivos/imunologia , Dieta/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Fatores Imunológicos/efeitos adversos , Masculino , Pessoa de Meia-Idade , Países Baixos , Plasma/virologia , Resultado do Tratamento , Carga ViralRESUMO
The purpose of this study was to evaluate the performance of bioimpedance analysis (BIA) in the prediction of total body water and fat free mass with the use of standard equations in assessing 20 prepubertal children infected with human immunodeficiency virus (HIV). Total body water was measured by means of deuterium oxide dilution, fat free mass by means of total body dual X-ray absorptiometry, and BIA with a bioelectrical impedance analyzer. The use of standard prediction equations resulted in substantial error. Regression equations using height and BIA resistance for estimating total body water and fat free mass were developed and appear to improve accuracy for prediction. This study suggests that total body water and fat free mass can be estimated in children with HIV by means of BIA equations specifically developed for use with this group of children.