HIV-1 Infection Clinical Trial
Official title:
Probiotic Visbiome for Inflammation and Translocation in HIV I (PROOV IT I)
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.
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