Clinical trial NCT03329560: Safety of FMT Using Oral Encapsulated PRIM-DJ2727 in HIV
Official title: Safety of Fecal Microbiota Transplant Using Oral Encapsulated PRIM-DJ2727 in HIV-infected Persons on Antiretroviral Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV-1-infection
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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).

Primary outcomes:
measure: Number of participants with adverse events related to study drug
timeFrame: 52 weeks
measure: Cumulative of adverse events related to study drug
timeFrame: 52 weeks
measure: Severity of adverse events related to study drug
timeFrame: 52 weeks
Secondary outcomes:
measure: Change in the intestinal microbiome diversity
timeFrame: week 0, week 6
measure: Change in the intestinal microbiome abundance of genera
timeFrame: week 0, week 6
measure: Change in systemic inflammation as assessed by interleukin 6 (IL-6) levels
timeFrame: week 0, week 6
measure: Change in microbial translocation as assessed by soluble cluster of differentiation (CD14) levels
timeFrame: week 0, week 6
measure: Change in gut barrier integrity as assessed by intestinal fatty acid binding protein (I-FABP)
timeFrame: week 0, week 6
Other outcomes:
Locations:
city: Houston
country: United States
facility: Thomas Street Health Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Netanya S Utay, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.