Combined antiretroviral therapy (cART)-treated patients have increased mortality and morbidity compared to age-matched seronegative individuals. This increased mortality and morbidity has been associated to immune activation that persists also in patients under cART even with undetectable levels of HIV-RNA in blood. Indeed, HIV-infected patients, irrespective of cART treatment, show higher levels of activated T cells, inflammatory monocytes and proinflammatory cytokines than seronegative individuals. Several putative causes of this residual inflammation have been proposed and include ongoing HIV replication at low levels, the presence of coinfections such as cytomegalovirus, and microbial translocation. None of these causes are mutually exclusive and understanding the degree to which of these three cause residual inflammation in cART-treated individuals will require novel therapeutic interventions aimed at alleviated each putative cause. In this longitudinal study we aim: 1. to reduce microbial translocation induced inflammation in cART-treated individuals with supplementation of cART with the probiotics. 2. to investigate the potential benefits of 24 weeks of probiotics supplementation on immune function and on immune activation status Indeed, the early stage of HIV infection is associated with dysbiosis of the GI tract microbiome with reducted levels of bifidobacteria and lactobacillus species with increased levels of potentially pathogenic proteobacteria species.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
probiotics (Streptococcus salivarius ssp. termophilus, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus delbrueckii ssp. bulgaricus and Streptococcus faecium)
Department of Public Health and Infectious Diseases, University of Rome "Sapienza", Italy
Rome, RM, Italy
Department of Public Health and Infectious Diseases. University of Rome "Sapienza" (Italy)
Rome, Italy
Delta of Cluster of Differentiation 4 (CD4)+/Cluster of Differentiation 38 (CD38)-/Human Leukocyte Antigen-D related (HLA-DR+)
Delta of CD4+/CD38-/HLA-DR+ in blood (T0-T1)
Time frame: 3 months
Delta of Cluster of Differentiation 8 (CD8)+/CD38+/HLA-DR+
Delta of CD8+/CD38-/HLA-DR+ in blood (T0-T1)
Time frame: 3 months
CD4 recovery (ΔCD4)
CD4 recovery (ΔCD4),in blood at T0 and T1
Time frame: 3 months
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