Can Probiotics Reduce Inflammation and Enhance Gut Immune Health in People Living with HIV: Study Designs for the Probiotic Visbiome for Inflammation and Translocation (PROOV IT) Pilot Trials

Figures & data

Table 1 Inclusion and exclusion criteria for PROOV IT I and II

Inclusion	Exclusion (PROOV IT I and II)
PROOV IT I documented HIV-1 infection adult male (age > 18 years) cART-naïve ability to provide informed consent HIV-1 viral load ≥ 1,000 copies/ml	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 colitis liver fibrosis (decompensated cirrhosis), portal hypertension or clinical hepatitis other significant underlying disease (non-HIV-1) that might increase the risk of disease progression or death
PROOV IT II documented HIV-1 infection adult male (age > 18 years) on antiretroviral therapy (>2 years but < 10 years) ability to provide informed consent HIV-1 viral load <49 copies/ml for the past 2 years CD4 T-cell count <350/mm3 for the last 2 years

Figure 1. Study design and study visit schedule for the (a) PROOV IT I double-blind and open-label portion, and (b) PROOV IT II studies.