Status:
COMPLETED
Safety of FMT Using Oral Encapsulated PRIM-DJ2727 in HIV
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
HIV-1-infection
Eligibility:
MALE
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03329560
Start Date
April 12 2018
End Date
October 8 2019
Last Update
May 27 2020
Active Locations (1)
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1
Thomas Street Health Center
Houston, Texas, United States, 77009