SHIFT: Studying HIV Immunology After Fecal Transplant (SHIFT)

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).

Study Overview

• Status: Withdrawn
• Conditions: Inflammation; HIV/AIDS; Dysbiosis
• Intervention / Treatment: Biological: Placebo (for Fecal Inoculum Capsule); Drug: Antibiotic Placebo; Biological: Fecal Inoculum Capsule; Drug: Antibiotic

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.

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Arm A; Weekly placebo (for Fecal Inoculum Capsule) treatment with placebo pre-treatment.	Biological: Placebo (for Fecal Inoculum Capsule); Placebo capsule manufactured to mimic Fecal Inoculum Capsules; Other Names: Placebo; Drug: Antibiotic Placebo; Placebo tablets manufactured to mimic antibiotics
Experimental: Arm B; Weekly Fecal Inoculum Capsule treatment with placebo pre-treatment.	Drug: Antibiotic Placebo; Placebo tablets manufactured to mimic antibiotics; Biological: Fecal Inoculum Capsule; Sieved fecal matter prepared in glycerol/saline solution
Experimental: Arm C; Weekly Fecal Inoculum Capsule treatment with antibiotic pre-treatment.	Biological: Fecal Inoculum Capsule; Sieved fecal matter prepared in glycerol/saline solution; Drug: Antibiotic; Antibiotic pre-treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FMT-related adverse events	Safety of FMT in stably suppressed HIV infected recipients on ART	30 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune and metabolic markers	Changes in immune and metabolic markers such as CD4 T cell activation and sCD14 levels.	30 weeks
Microbiome structure	Identify and characterize how FMT alters enteric microbiome structure.	30 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Douglas Kwon, MD, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2018
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (Actual): May 23, 2017

Study Record Updates

• Last Update Posted (Actual): November 15, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Dysbiosis; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: 2016P002317

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No