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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Withdrawn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
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV/AIDS

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

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

    First Posted
    May 18, 2017
    Last Updated
    November 13, 2018
    Sponsor
    Massachusetts General Hospital
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    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

    Learn more about this trial

    SHIFT: Studying HIV Immunology After Fecal Transplant

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