Safety of FMT Using Oral Encapsulated PRIM-DJ2727 in HIV

Phase 1

Completed

• Conditions: HIV-1-infection
• Interventions: Biological: Oral fecal microbiota transplantation

• Registration Number: NCT03329560
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-30
• Study First Submitted QC: 2017-10-30
• Study First Posted: 2017-11-06
• Study Start: 2018-04-12
• Primary Completion: 2019-10-08
• Study Completion: 2019-10-08
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-24
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral fecal microbiota transplantation	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.

Primary Outcome Measures

Name	Time	Method
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	52 weeks	Severity of adverse events will be based on Division of AIDS (DAIDS) grading criteria.

Secondary Outcome Measures

Name	Time	Method
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 gut barrier integrity as assessed by intestinal fatty acid binding protein (I-FABP)	week 0, week 6
Change in microbial translocation as assessed by soluble cluster of differentiation (CD14) levels	week 0, week 6

Trial Locations

Locations (1)

Thomas Street Health Center; 🇺🇸 Houston, Texas, United States