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

University Health Network, Toronto

Status and phase

Terminated

Phase 2

Conditions

HIV-1 Infection

Treatments

Drug: Visbiome

Other: Placebo

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT02441244

CTNPT 022A

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

Male

Ages

19+ years old

Volunteers

No Healthy Volunteers

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