Safety of FMT Using Oral Encapsulated PRIM-DJ2727 in HIV

HIV-1-infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03329560
• Other study ID #: HSC-MS-17-0782
• Status: Completed
• Phase: Phase 1
• Start date: April 12, 2018
• Est. completion date: October 8, 2019

Study information

• Verified date: May 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 8, 2019
• Est. primary completion date: October 8, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

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.

Locations

Country	Name	City	State
United States	Thomas Street Health Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events related to study drug		52 weeks
Primary	Cumulative of adverse events related to study drug		52 weeks
Primary	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	Change in the intestinal microbiome diversity		week 0, week 6
Secondary	Change in the intestinal microbiome abundance of genera		week 0, week 6
Secondary	Change in systemic inflammation as assessed by interleukin 6 (IL-6) levels		week 0, week 6
Secondary	Change in microbial translocation as assessed by soluble cluster of differentiation (CD14) levels		week 0, week 6
Secondary	Change in gut barrier integrity as assessed by intestinal fatty acid binding protein (I-FABP)		week 0, week 6