HIV-1 Infection Clinical Trial
Official title:
Probiotic Visbiome for Inflammation and Translocation in HIV II (PROOV IT II)
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 very common among people living with
HIV, with estimates ranging from 16-60%. 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 ART will improve
gut CD4 T cell restoration and function and therefore reduce microbial translocation and
immune activation.
A major challenge to HIV treatment is the suboptimal CD4 T cell count despite successful HIV
suppression on ART in immunologic non-responders (INRs). These individuals are at increased
risk of AIDS-related deaths and non-AIDS related comorbidities that may be associated with
increased immune activation and microbial translocation from the gut mucosa. With limited
treatment options, alternative therapies to reduce inflammation and restore gut immunology
will be important. 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 an immunoregualtory
phenotype with increased the levels of IL-10 and reduced levels of proinflammatory cytokines
(TNFα, IL1β and IL-8). Therefore,the investigators believe that the "beneficial" bacteria
from Visbiome will accelerate the normalization of gut immune cells and function in
HIV-infected INRs. It is hypothesized consumption of Visbiome for 48 weeks will help restore
the immune system in INRs who have suboptimal immune reconstitution to currently available
ART. Resolution of gut immune cells will mean that microbial translocation and immune
activation will be normalized and will reduce the rates of HIV-associated comorbidities.
n/a
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