Clinical trial NCT03163784: SHIFT: Studying HIV Immunology After Fecal Transplant
Official title: SHIFT: Studying HIV Immunology After Fecal Transplant
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: HIV/AIDS
Dysbiosis
Inflammation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: FMT-related adverse events
timeFrame: 30 weeks
Secondary outcomes:
measure: Immune and metabolic markers
timeFrame: 30 weeks
measure: Microbiome structure
timeFrame: 30 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Douglas Kwon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: