CClinicalTrials.gg
Sign In
CompletedNCT03329560Updated May 27, 2020

Safety of FMT Using Oral Encapsulated PRIM-DJ2727 in HIV

A Phase 1 interventional study of Oral fecal microbiota transplantation in HIV-1-infection, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-27.

Sponsored by The University of Texas Health Science Center, Houston · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • HIV-1-infection
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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).
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • 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

Interventions

  • BiologicalOral 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.

    Also known as: PRIM-DJ2727

05

What researchers measure

Primary outcomes

  1. Number of participants with adverse events related to study drug

    Time frame: 52 weeks

  2. Cumulative of adverse events related to study drug

    Time frame: 52 weeks

  3. Severity of adverse events related to study drug

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

    Time frame: 52 weeks

Secondary outcomes

  1. Change in the intestinal microbiome diversity

    Time frame: week 0, week 6

  2. Change in the intestinal microbiome abundance of genera

    Time frame: week 0, week 6

  3. Change in systemic inflammation as assessed by interleukin 6 (IL-6) levels

    Time frame: week 0, week 6

  4. Change in microbial translocation as assessed by soluble cluster of differentiation (CD14) levels

    Time frame: week 0, week 6

  5. Change in gut barrier integrity as assessed by intestinal fatty acid binding protein (I-FABP)

    Time frame: week 0, week 6

06

Study locations

1 site
  • Thomas Street Health Center
    Houston, Texas 77009, United States
07

References and documents

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. PubMed 33501400 ↗
08

Registry details

Key details

Study ID
NCT03329560
Lead sponsor
The University of Texas Health Science Center, Houston
Responsible party
Netanya Utay (Assistant Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Nov 6, 2017
Start date
Apr 12, 2018
Primary completion
Oct 8, 2019
Completion
Oct 8, 2019
Last update
May 27, 2020

Study contacts

Netanya S Utay, MD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

The University of Texas Health Science Center, Houston

Start the discussion