SHIFT: Studying HIV Immunology After Fecal Transplant

Mass General Brigham

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Dysbiosis; Inflammation; HIV/AIDS

Treatments: Drug: Antibiotic Placebo; Biological: Placebo (for Fecal Inoculum Capsule); Drug: Antibiotic; Biological: Fecal Inoculum Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03163784

2016P002317

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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0 participants in 3 patient groups, including a placebo group

Arm A

Placebo Comparator group

Description:

Weekly placebo (for Fecal Inoculum Capsule) treatment with placebo pre-treatment.

Treatment:

Drug: Antibiotic Placebo

Biological: Placebo (for Fecal Inoculum Capsule)

Arm B

Experimental group

Description:

Weekly Fecal Inoculum Capsule treatment with placebo pre-treatment.

Treatment:

Biological: Fecal Inoculum Capsule

Drug: Antibiotic Placebo

Arm C

Experimental group

Description:

Weekly Fecal Inoculum Capsule treatment with antibiotic pre-treatment.

Treatment:

Biological: Fecal Inoculum Capsule

Drug: Antibiotic