Dysbiosis, HIV/AIDS, Inflammation
Conditions
Brief summary
SHIFT is a randomized, longitudinal, prospective, blinded, three-arm study to determine the safety and tolerability of Fecal Microbiota Transplant (FMT) in HIV-infected participants on stable antiretroviral therapy (ART).
Detailed description
This study is designed to test the safety and tolerability of Fecal Microbiota Transplant (FMT) in HIV infected individuals on stable antiretroviral therapy (ART). Additionally, the study will examine potential effects of FMT on HIV immune activation, which has been linked to HIV disease progression.
Interventions
BIOLOGICALFecal Inoculum Capsule
Sieved fecal matter prepared in glycerol/saline solution
BIOLOGICALPlacebo (for Fecal Inoculum Capsule)
Placebo capsule manufactured to mimic Fecal Inoculum Capsules
DRUGAntibiotic
Antibiotic pre-treatment
DRUGAntibiotic Placebo
Placebo tablets manufactured to mimic antibiotics
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Men and women ages 18 - 75 years. 2. HIV-1 positive: 3. Ability and willingness of participant or legal guardian/representative to provide informed consent.
Exclusion criteria
1. Patients with a history of significant allergy to tree nuts, peanuts, shellfish, and/or eggs, vancomycin, levofloxacin, or metronidazole, chocolate/cocoa or gelatin; or unwillingness to ingest gelatin (in placebo capsules) 2. Use of investigational therapies or investigational vaccines within 90 days prior to study entry 3. Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry 4. History of positive HCV antibody with detectable HCV RNA in plasma within 48 weeks prior to study entry. 5. History of positive HBsAg within 48 weeks prior to study entry 6. Liver cirrhosis, history of C. difficile infection, history of inflammatory bowel disease, bariatric surgery, total colectomy, colon or rectal anastomosis, bowel resection, or current colostomy. 7. Current diagnosis of diabetes 8. BMI \>35 9. Either breastfeeding or pregnant within 24 weeks prior to study entry 10. Tendinopathy or peripheral neuropathy (potentially exacerbated by antibiotic pretreatment) 11. Use of immunosuppressives, immune modulators, or antineoplastic agents for more than 3 consecutive days within the 60 days prior to study entry. 12. Use of probiotics and prebiotics (supplements and products) within 30 days of the study. Yogurt with live cultures is allowed. 13. Diagnosed bacterial enteric infection within 30 days prior to study entry. 14. Acute diarrhea within 30 days of study entry. 15. Weight loss or gain of more than 25 pounds in the 24 weeks prior to study entry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FMT-related adverse events | 30 weeks | Safety of FMT in stably suppressed HIV infected recipients on ART |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiome structure | 30 weeks | Identify and characterize how FMT alters enteric microbiome structure. |
| Immune and metabolic markers | 30 weeks | Changes in immune and metabolic markers such as CD4 T cell activation and sCD14 levels. |
Outcome results
None listed