Safety of FMT Using Oral Encapsulated PRIM-DJ2727 in HIV

Inclusion criteria

• HIV-1 infection, documented by any licensed HIV test
• Male subjects ≥ 18 years of age
• Identify as MSM (men who have sex with men)
• Currently on continuous ART for ≥24 weeks prior to study entry with no change in the ART regimen within the 12 weeks prior to study
• Ability and willingness of the participating subject to sign the informed consent form
• No plan to change ART regimen for the study duration
• Screening CD4+ cell count >350 cells/mm3 obtained within 45 days prior to study entry
• HIV RNA < 20 copies/ml for ≥12 weeks (1 blip of < 500 copies/ml will be permitted)
• Absolute neutrophil count ≥ 1000 cells/mm3

Exclusion criteria

• Initiation of ART during acute/early HIV infection (within 6 months of HIV seroconversion)
• Co-infection with Hepatitis B (positive HBsAg or positive HBcAb total with detectable HBV DNA levels) or Hepatitis C (positive HCV IgG with detectable HCV RNA levels)
• Use of antibiotics 60 days prior to the study entry
• Use of investigational therapies or vaccines 60 days prior to the study entry
• Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry
• Cirrhosis, inflammatory bowel disease, total colectomy, colon or rectal anastomosis, bowel resection, or current colostomy
• Diabetes mellitus
• Any episode of acute or persistent diarrhea within 60 days prior to study entry
• Use of any of the following medications/products for more than 3 consecutive days within the 60 days prior to study entry: Immunosuppressives, Immune modulators, Antineoplastic agents (except for topical agents for skin cancer), Probiotics and prebiotics (supplements and products).