Clincosm LogoSign in Get a demo

SHIFT: Studying HIV Immunology After Fecal Transplant

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03163784
Collaborator
(none)
0
Enrollment
3
Arms
48
Anticipated Duration (Months)

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Biological: Fecal Inoculum Capsule
  • Biological: Placebo (for Fecal Inoculum Capsule)
  • Drug: Antibiotic
  • Drug: Antibiotic Placebo
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
SHIFT: Studying HIV Immunology After Fecal Transplant
Anticipated Study Start Date :
Jun 1, 2018
Anticipated Primary Completion Date :
Jun 1, 2020
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

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.

    Biological: Fecal Inoculum Capsule
    Sieved fecal matter prepared in glycerol/saline solution

    Drug: Antibiotic Placebo
    Placebo tablets manufactured to mimic antibiotics
    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

    Outcome Measures

    Primary Outcome Measures

    1. FMT-related adverse events [30 weeks]

      Safety of FMT in stably suppressed HIV infected recipients on ART

    Secondary Outcome Measures

    1. Immune and metabolic markers [30 weeks]

      Changes in immune and metabolic markers such as CD4 T cell activation and sCD14 levels.

    2. Microbiome structure [30 weeks]

      Identify and characterize how FMT alters enteric microbiome structure.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Massachusetts General Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    DOUGLAS KWON, Principal Investigator, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT03163784
    Other Study ID Numbers:
    • 2016P002317
    First Posted:
    May 23, 2017
    Last Update Posted:
    Nov 15, 2018
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Inflammation
    Dysbiosis
    Anti-Bacterial Agents
    Antibiotics, Antitubercular

    Study Results

    No Results Posted as of Nov 15, 2018