Probiotic Visbiome for Inflammation and Translocation in HIV Ι (PROOV IT I)

Recruitment potential impaired by shift in clinical care whereby practically all HIV patients receive standard treatment as soon as possible after HIV diagnosis

Modern antiretroviral therapy (ART) has transformed the clinical care and lived experience of HIV infection. However, increased rates of adverse health conditions that are related to immune activation, such as cardiovascular disease (CVD) and neurodegenerative disease in ART-treated individuals persist. An important cause of this inflammation is the gut CD4 T cell loss and the "leaking" or translocation of luminal gut bacteria and other microbes across the bowel wall and into the bloodstream. The use of complementary and alternative therapies is common among people living with HIV, however their efficacy has generally not been well demonstrated. Probiotics are live microbes that may provide a health benefit to the host and the investigators believe that the simultaneous use of probiotics along with antiretroviral therapy (ART) will improve gut CD4 T cell restoration and function and therefore reduce microbial translocation and immune activation. Probiotic Visbiome consists of a high potency blend of eight different probiotics. The precise mechanism of action of Visbiome is unknown, but preclinical studies have shown that Visbiome may modulate the immune response towards a phenotype that is associated with reduce inflammation, and Visbiome was also protective in a non-human primate model of SIV infection. Therefore, we believe that the "beneficial" bacteria from Visbiome will accelerate the normalization of gut immune cells and function in HIV-infected individuals as they start ART. Early resolution of gut immune cells may normalize microbial translocation and immune activation and will reduce the rates of HIV-associated comorbidities.

Percent of blood immune activation (coexpression of CD38 and HLA-DR) on CD8 T cells at week 24 in participants randomized to probiotic Visbiome versus the placebo arm

Percent of blood immune activation (coexpression of CD38 and HLA-DR) on CD8 T cells at week 24 in participants randomized to probiotic Visbiome versus the placebo arm

Inclusion Criteria: Documented HIV-1 infection Male adult (age >18 years) Antiretroviral therapy-naïve Ability to provide informed consent HIV-1 viral load ≥1,000 copies/ml Exclusion Criteria: Current alcohol or substance use judged by the Investigator to potentially interfere with participant study compliance Taking pharmaceutical grade probiotics Any of the following abnormal laboratory results in screening: Hemoglobin <85 g/L Neutrophil count <750 cells/μl Platelet count <50,000 cells/μl AST or ALT >5X the upper limit of normal Malignancy Colitis Liver fibrosis (decompensated cirrhosis), portal hypertension or clinical hepatitis Other significant underlying disease (non-HIV-1) that might impinge upon disease progression or death