Safety of FMT Using Oral Encapsulated PRIM-DJ2727 in HIV
NCT ID: NCT03329560
Last Updated: 2020-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
6 participants
INTERVENTIONAL
2018-04-12
2019-10-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
MALE
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Netanya Utay
Assistant Professor
Principal Investigators
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Netanya S Utay, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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Thomas Street Health Center
Houston, Texas, United States
Countries
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References
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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.
Other Identifiers
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HSC-MS-17-0782
Identifier Type: -
Identifier Source: org_study_id
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