Safety of FMT Using Oral Encapsulated PRIM-DJ2727 in HIV

NCT03329560 | Completed Phase 1 FDA Drug

• 1 other identifier: HSC-MS-17-0782
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

Study Arms (1)

Oral fecal microbiota transplantation

EXPERIMENTAL

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

Interventions

Oral fecal microbiota transplantation BIOLOGICAL

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.

Also known as: PRIM-DJ2727

Oral fecal microbiota transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Thomas Street Health Center

Houston, Texas, 77009, United States

Location

Related Publications (1)

• 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.

  PMID: 33501400 DERIVED

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Netanya S Utay, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 6, 2017
• Study Start: April 12, 2018
• Primary Completion: October 8, 2019
• Study Completion: October 8, 2019
• Last Updated: May 27, 2020

Record last verified: 2020-05

Locations

US (1)