Safety of FMT Using Oral Encapsulated PRIM-DJ2727 in HIV

Safety of Fecal Microbiota Transplant Using Oral Encapsulated PRIM-DJ2727 in HIV-infected Persons on Antiretroviral Therapy

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

Study Overview

• Status: Completed
• Conditions: HIV-1-infection
• Intervention / Treatment: Biological: Oral fecal microbiota transplantation

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77009
      • Thomas Street Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events related to study drug		52 weeks
Cumulative of adverse events related to study drug		52 weeks
Severity of adverse events related to study drug	Severity of adverse events will be based on Division of AIDS (DAIDS) grading criteria.	52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in the intestinal microbiome diversity	week 0, week 6
Change in the intestinal microbiome abundance of genera	week 0, week 6
Change in systemic inflammation as assessed by interleukin 6 (IL-6) levels	week 0, week 6
Change in microbial translocation as assessed by soluble cluster of differentiation (CD14) levels	week 0, week 6
Change in gut barrier integrity as assessed by intestinal fatty acid binding protein (I-FABP)	week 0, week 6

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Utay NS, Monczor AN, Somasunderam A, Lupo S, Jiang ZD, Alexander AS, Finkelman M, Vigil KJ, Lake JE, Hanson B, DuPont HL, Arduino RC. Evaluation of Six Weekly Oral Fecal Microbiota Transplants in People with HIV. Pathog Immun. 2020 Dec 30;5(1):364-381. doi: 10.20411/pai.v5i1.388. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2018
• Primary Completion (Actual): October 8, 2019
• Study Completion (Actual): October 8, 2019

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: October 30, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 24, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HSC-MS-17-0782

Drug and device information, study documents

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