SHIFT: Studying HIV Immunology After Fecal Transplant (SHIFT)
Primary Purpose
HIV/AIDS, Dysbiosis, Inflammation
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Fecal Inoculum Capsule
Placebo (for Fecal Inoculum Capsule)
Antibiotic
Antibiotic Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for HIV/AIDS
Eligibility Criteria
Inclusion Criteria:
- Men and women ages 18 - 75 years.
- HIV-1 positive:
- Ability and willingness of participant or legal guardian/representative to provide informed consent.
Exclusion Criteria:
- 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)
- Use of investigational therapies or investigational vaccines within 90 days prior to study entry
- Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry
- History of positive HCV antibody with detectable HCV RNA in plasma within 48 weeks prior to study entry.
- History of positive HBsAg within 48 weeks prior to study entry
- 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.
- Current diagnosis of diabetes
- BMI >35
- Either breastfeeding or pregnant within 24 weeks prior to study entry
- Tendinopathy or peripheral neuropathy (potentially exacerbated by antibiotic pretreatment)
- Use of immunosuppressives, immune modulators, or antineoplastic agents for more than 3 consecutive days within the 60 days prior to study entry.
- Use of probiotics and prebiotics (supplements and products) within 30 days of the study. Yogurt with live cultures is allowed.
- Diagnosed bacterial enteric infection within 30 days prior to study entry.
- Acute diarrhea within 30 days of study entry.
- Weight loss or gain of more than 25 pounds in the 24 weeks prior to study entry.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Arm A
Arm B
Arm C
Arm Description
Weekly placebo (for Fecal Inoculum Capsule) treatment with placebo pre-treatment.
Weekly Fecal Inoculum Capsule treatment with placebo pre-treatment.
Weekly Fecal Inoculum Capsule treatment with antibiotic pre-treatment.
Outcomes
Primary Outcome Measures
FMT-related adverse events
Safety of FMT in stably suppressed HIV infected recipients on ART
Secondary Outcome Measures
Immune and metabolic markers
Changes in immune and metabolic markers such as CD4 T cell activation and sCD14 levels.
Microbiome structure
Identify and characterize how FMT alters enteric microbiome structure.
Full Information
NCT ID
NCT03163784
First Posted
May 18, 2017
Last Updated
November 13, 2018
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03163784
Brief Title
SHIFT: Studying HIV Immunology After Fecal Transplant
Acronym
SHIFT
Official Title
SHIFT: Studying HIV Immunology After Fecal Transplant
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Withdrawn
Why Stopped
The study closed because of shifting research priorities and interests.
Study Start Date
June 2018 (Anticipated)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Dysbiosis, Inflammation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Placebo Comparator
Arm Description
Weekly placebo (for Fecal Inoculum Capsule) treatment with placebo pre-treatment.
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Weekly Fecal Inoculum Capsule treatment with placebo pre-treatment.
Arm Title
Arm C
Arm Type
Experimental
Arm Description
Weekly Fecal Inoculum Capsule treatment with antibiotic pre-treatment.
Intervention Type
Biological
Intervention Name(s)
Fecal Inoculum Capsule
Intervention Description
Sieved fecal matter prepared in glycerol/saline solution
Intervention Type
Biological
Intervention Name(s)
Placebo (for Fecal Inoculum Capsule)
Other Intervention Name(s)
Placebo
Intervention Description
Placebo capsule manufactured to mimic Fecal Inoculum Capsules
Intervention Type
Drug
Intervention Name(s)
Antibiotic
Intervention Description
Antibiotic pre-treatment
Intervention Type
Drug
Intervention Name(s)
Antibiotic Placebo
Intervention Description
Placebo tablets manufactured to mimic antibiotics
Primary Outcome Measure Information:
Title
FMT-related adverse events
Description
Safety of FMT in stably suppressed HIV infected recipients on ART
Time Frame
30 weeks
Secondary Outcome Measure Information:
Title
Immune and metabolic markers
Description
Changes in immune and metabolic markers such as CD4 T cell activation and sCD14 levels.
Time Frame
30 weeks
Title
Microbiome structure
Description
Identify and characterize how FMT alters enteric microbiome structure.
Time Frame
30 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women ages 18 - 75 years.
HIV-1 positive:
Ability and willingness of participant or legal guardian/representative to provide informed consent.
Exclusion Criteria:
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)
Use of investigational therapies or investigational vaccines within 90 days prior to study entry
Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry
History of positive HCV antibody with detectable HCV RNA in plasma within 48 weeks prior to study entry.
History of positive HBsAg within 48 weeks prior to study entry
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.
Current diagnosis of diabetes
BMI >35
Either breastfeeding or pregnant within 24 weeks prior to study entry
Tendinopathy or peripheral neuropathy (potentially exacerbated by antibiotic pretreatment)
Use of immunosuppressives, immune modulators, or antineoplastic agents for more than 3 consecutive days within the 60 days prior to study entry.
Use of probiotics and prebiotics (supplements and products) within 30 days of the study. Yogurt with live cultures is allowed.
Diagnosed bacterial enteric infection within 30 days prior to study entry.
Acute diarrhea within 30 days of study entry.
Weight loss or gain of more than 25 pounds in the 24 weeks prior to study entry.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Kwon, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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SHIFT: Studying HIV Immunology After Fecal Transplant
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