Effects of Immunonutrition in Advanced Human Immunodeficiency Virus Disease: A Randomized Placebo-controlled Clinical Trial (Promaltia Study)
Por:
Serrano-Villar S, de Lagarde M, Vázquez-Castellanos J, Vallejo A, Bernadino JI, Madrid N, Matarranz M, Díaz-Santiago A, Gutiérrez C, Cabello A, Villar-García J, Blanco JR, Bisbal O, Sainz T, Moya A, Moreno S, Gosalbes MJ and Estrada V
Publicada:
1 ene 2019
Resumen:
Background. While nutritional interventions with prebiotics and probiotics seem to exert immunological effects, their clinical implications in human immunodeficiency virus (HIV)-infected subjects initiating antiretroviral therapy (ART) at advanced HIV disease remain unclear.
Methods. This was a pilot multicenter randomized, placebo-controlled, double-blind study in which 78 HIV-infected, ART-naive subjects with <350 CD4 T cells/mu L or AIDS were randomized to either daily PMT25341 (a mixture of synbiotics, omega-3/6 fatty acids and amino acids) or placebo for 48 weeks, each in combination with first-line ART. Primary endpoints were changes in CD4 T-cell counts and CD4/CD8 ratio from baseline to week 48 and safety. Secondary endpoints were changes in markers of T-cell activation, bacterial translocation, inflammation, and a and beta microbiota diversity.
Results. Fifty-nine participants completed the follow-up with a mean CD4(+) T-cell count of 221 +/- 108 cells/mu L and mean CD4/CD8 ratio of 0.26 +/- 0.19. PMT25341 was well tolerated, without grade 3-4 adverse effects attributable to the intervention. While most of the assessed biomarkers improved during the follow-up in both arms, PMT25341-treated subjects did not experience any significant change, compared to placebo-treated subjects, in mean CD4(+) T-cell count change (278 vs 250 cells/mu L, P = .474) or CD4/CD8 ratio change (0.30 vs 0.32, P = .854). Similarly, we did not detect differences between treatment arms in secondary endpoints.
Conclusions. In HIV-infected patients initiating ART at advanced disease, the clear immunological benefits of ART were not enhanced by this nutritional intervention targeting the gut-associated lymphoid tissue and microbiota.
Filiaciones:
:
Department of Infectious Diseases, Hospital Universitario Ramon y Cajal, Facultad de Medicina, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid
de Lagarde M:
HIV Unit, Hospital Universitario Doce de Octubre, Madrid
:
Area of Genomics and Health, FISABIO-Salud Pública, Valencia
Vallejo A:
Department of Infectious Diseases, Hospital Universitario Ramon y Cajal, Facultad de Medicina, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid
Bernadino JI:
HIV Unit, Hospital Universitario La Paz, Instituto de Investigación Hospital Universitario La Paz (IdiPAZ), Madrid
Madrid N:
Department of Infectious Diseases, Hospital Universitario Ramon y Cajal, Facultad de Medicina, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid
Matarranz M:
HIV Unit, Hospital Universitario Doce de Octubre, Madrid
Díaz-Santiago A:
Department of Infectious Diseases, Hospital Universitario Ramon y Cajal, Facultad de Medicina, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid
Gutiérrez C:
Department of Infectious Diseases, Hospital Universitario Ramon y Cajal, Facultad de Medicina, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid
Cabello A:
Infectious Diseases Division, Hospital Universitario Fundación Jiménez Díaz, Madrid
Villar-García J:
Infectious Diseases Department, Hospital del Mar, Instituto Hospital del Mar de Investigaciones Médicas (IMIM), Barcelona
Blanco JR:
Department of Infectious Diseases, Hospital San Pedro - Centro de Investigación Biomédica de la Rioja (CIBIR), Logroño
Bisbal O:
HIV Unit, Hospital Universitario Doce de Octubre, Madrid
Sainz T:
Pediatric Tropical and Infectious Diseases Department, Hospital Universitario La Paz, Instituto de Investigación Hospital Universitario La Paz (IdiPAZ), Valencia
:
Area of Genomics and Health, FISABIO-Salud Pública, Valencia
Institute of Integrative Systems Biology, University of Valencia and CSIC, Valencia
CIBER in Epidemiology and Public Health, Madrid
Moreno S:
HIV Unit, Hospital Universitario Doce de Octubre, Madrid
:
Area of Genomics and Health, FISABIO-Salud Pública, Valencia
CIBER in Epidemiology and Public Health, Madrid
Estrada V:
HIV Unit, Hospital Clínico San Carlos, Madrid, Spain
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