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Safety of FMT Using Oral Encapsulated PRIM-DJ2727 in HIV

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Completed
CT.gov ID
NCT03329560
Collaborator
(none)
6
Enrollment
1
Location
1
Arm
17.9
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether oral fecal microbiota transplantation (FMT) is safe for people with human immunodeficiency virus (HIV) infection.

Condition or Disease Intervention/Treatment Phase
  • Biological: Oral fecal microbiota transplantation
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety of Fecal Microbiota Transplant Using Oral Encapsulated PRIM-DJ2727 in HIV-infected Persons on Antiretroviral Therapy
Actual Study Start Date :
Apr 12, 2018
Actual Primary Completion Date :
Oct 8, 2019
Actual Study Completion Date :
Oct 8, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Oral fecal microbiota transplantation

All subjects will receive one dose per week for 6 weeks (6 total doses) of PRIM-DJ2727 oral capsules containing lyophilized microbiota product derived from 150 grams of healthy donor stool.

Biological: Oral fecal microbiota transplantation
All subjects will receive one dose per week for 6 weeks (6 total doses) of PRIM-DJ2727 oral capsules containing lyophilized microbiota product derived from 150 grams of healthy donor stool.
Other Names:
  • PRIM-DJ2727

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with adverse events related to study drug [52 weeks]

    2. Cumulative of adverse events related to study drug [52 weeks]

    3. Severity of adverse events related to study drug [52 weeks]

      Severity of adverse events will be based on Division of AIDS (DAIDS) grading criteria.

    Secondary Outcome Measures

    1. Change in the intestinal microbiome diversity [week 0, week 6]

    2. Change in the intestinal microbiome abundance of genera [week 0, week 6]

    3. Change in systemic inflammation as assessed by interleukin 6 (IL-6) levels [week 0, week 6]

    4. Change in microbial translocation as assessed by soluble cluster of differentiation (CD14) levels [week 0, week 6]

    5. Change in gut barrier integrity as assessed by intestinal fatty acid binding protein (I-FABP) [week 0, week 6]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • HIV-1 infection, documented by any licensed HIV test

    • Male subjects ≥ 18 years of age

    • Identify as MSM (men who have sex with men)

    • Currently on continuous ART for ≥24 weeks prior to study entry with no change in the ART regimen within the 12 weeks prior to study

    • Ability and willingness of the participating subject to sign the informed consent form

    • No plan to change ART regimen for the study duration

    • Screening CD4+ cell count >350 cells/mm3 obtained within 45 days prior to study entry

    • HIV RNA < 20 copies/ml for ≥12 weeks (1 blip of < 500 copies/ml will be permitted)

    • Absolute neutrophil count ≥ 1000 cells/mm3

    Exclusion Criteria:

    • Initiation of ART during acute/early HIV infection (within 6 months of HIV seroconversion)

    • Co-infection with Hepatitis B (positive HBsAg or positive HBcAb total with detectable HBV DNA levels) or Hepatitis C (positive HCV IgG with detectable HCV RNA levels)

    • Use of antibiotics 60 days prior to the study entry

    • Use of investigational therapies or vaccines 60 days prior to the study entry

    • Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry

    • Cirrhosis, inflammatory bowel disease, total colectomy, colon or rectal anastomosis, bowel resection, or current colostomy

    • Diabetes mellitus

    • Any episode of acute or persistent diarrhea within 60 days prior to study entry

    • Use of any of the following medications/products for more than 3 consecutive days within the 60 days prior to study entry: Immunosuppressives, Immune modulators, Antineoplastic agents (except for topical agents for skin cancer), Probiotics and prebiotics (supplements and products).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Thomas Street Health Center Houston Texas United States 77009

    Sponsors and Collaborators

    • The University of Texas Health Science Center, Houston

    Investigators

    • Principal Investigator: Netanya S Utay, MD, The University of Texas Health Science Center, Houston

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Netanya Utay, Assistant Professor, The University of Texas Health Science Center, Houston
    ClinicalTrials.gov Identifier:
    NCT03329560
    Other Study ID Numbers:
    • HSC-MS-17-0782
    First Posted:
    Nov 6, 2017
    Last Update Posted:
    May 27, 2020
    Last Verified:
    May 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 27, 2020