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ood were collected on Visit 1 and Visit 7 from each subject.HC = hydroxycarbamide. b AV-HALTs Lower Immune Activation and Viral Load separation, cryopreservation and storage of all samples collected until the Neuromedin N material was sent via international courier to ViroStatics laboratories in Pavia, Italy where the analyses were performed. The PBMCs were shipped using dry ice to avoid thawing of the material in transit and materials received by ViroStatics were immediately inspected to ensure thawing had not occurred. All laboratories involved used human materials sampled in the study only in accordance with the study protocol, the international Good Clinical Practice principles as stated in the ICH GCP guidelines, the EU Clinical Trial Directive, and other relevant legislative or regulatory requirements as was required by the site’s country. Gag response. Student’s t-test was used to assess differences in net spots/million PBMCs detected by ELISPOT assay. A value of P,.05 was considered statistically significant. Results Baseline Characteristics Eligible patients were chronically infected with HIV-1, at least 18 years old, weighed 60 kg or more, and HIV-1 antiretroviral treatment-naive with plasma HIV-1 RNA levels.5,000 copies/ mL and CD4+ T cell counts.250 cells/mm3. A total of 66 subjects were randomized into the study as seen in Flow Cytometry Analysis PBMCs isolated from 32 individuals at baseline and at Day 29 were thawed and stained with AmCyan antiCD4, PacificBlue anti-CD8, Alexa Fluor700 anti-CD3, APC anti-HLA-DR, PerCP-Cy5.5 anti-CD45RA, APC-Cy7 anti-CD27, FITC anti-PD1, ECD anti-CD69, and PE-Cy5 anti-CD38 for surface markers. For intracellular staining, samples were permeabilized with the BD Cytofix/CytopermTM Fixation/Permeabilization Solution Kit according to the manufacturer’s protocol. Cells were then stained with PE anti-Ki-67. PE – IgG1- isotype control was employed. This subgroup of 32 subjects had baseline characteristics and response to treatment similar to the overall cohort. Samples were analyzed by using a BD LSR-II flow cytometer supplied with DiVa 6.1 acquisition and analysis software. A minimum of 0.5 million events in the CD3+ T cell subset were acquired for all samples. Student’s and Wilcoxon non-parametric paired tests were used to evaluate the statistical significance of data obtained. P values,.05 were considered as significant. Safety ELISPOT Assay ELISPOT assays were carried out with PBMCs collected from a 22-subject subgroup. This subgroup had baseline characteristics and response to treatment similar to the overall cohort. Peptides used in this study were obtained from the National Institutes of Health AIDS Research and ~~ The gut microbiota impacts various aspects of host physiology including modulation of the immune system. Overall balance in composition of the microbiota, together with the influence of pivotal species that induce specific responses are important determinants of immunity in the intestine and beyond. Non-pathogenic bacteria that promote beneficial health effects when ingested have been termed probiotics. These “beneficial microbes”are most frequently Lactobacillus or Bifidobacterium species, however a number of lactic acid bacteria and nonpathogenic E.coli have also been identified as probiotics. While initial attention was focused on the role of probiotics in gastrointestinal development, immune adaptation and attenuation of GI inflammatory diseases there is increasing interest in the ability

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