HIV-1-infection
Conditions
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.
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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Change in microbial translocation as assessed by soluble cluster of differentiation (CD14) levels | week 0, week 6 |
| Change in the intestinal microbiome diversity | 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 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 |
Countries
United States
Outcome results
None listed