NCT02441244: PROOV IT I

Probiotic Visbiome for Inflammation and Translocation in HIV Ι

Terminated Phase 2 Last updated 1 March 2018

What this trial tests

Phase 2 trial testing Visbiome in HIV-1 Infection in 1 participant. Terminated before completion.

Timeline

15 November 2015

Primary endpoint
19 December 2016

19 December 2016

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	1
Start date	15 November 2015
Primary completion	19 December 2016
Estimated completion	19 December 2016
Sites	2 locations across Canada

Drugs / interventions tested

• Visbiome — full drug profile →
• Placebo

Conditions studied

• HIV-1 Infection — all drugs for HIV-1 Infection →

Sponsor

University Health Network, Toronto

Who can join

19 and older, male only, with HIV-1 Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Coronary Artery Disease in HIV-Infected Patients: Downside of Living Longer.
   Lacson JC, Barnes RP, Bahrami H. · · 2017 · cited 29× · PMID 28265887 · DOI 10.1007/s11883-017-0651-4