Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-02-26 @ 12:43 AM
Study NCT ID:
NCT03329560
Status:
COMPLETED
Last Update Posted:
2020-05-27
First Post:
2017-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of FMT Using Oral Encapsulated PRIM-DJ2727 in HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-24', 'studyFirstSubmitDate': '2017-10-30', 'studyFirstSubmitQcDate': '2017-10-30', 'lastUpdatePostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': 'Severity of adverse events will be based on Division of AIDS (DAIDS) grading criteria.'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV-1-infection']}, 'referencesModule': {'references': [{'pmid': '33501400', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether oral fecal microbiota transplantation (FMT) is safe for people with human immunodeficiency virus (HIV) infection.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1 infection, documented by any licensed HIV test\n* Male subjects ≥ 18 years of age\n* Identify as MSM (men who have sex with men)\n* 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\n* Ability and willingness of the participating subject to sign the informed consent form\n* No plan to change ART regimen for the study duration\n* Screening CD4+ cell count \\>350 cells/mm3 obtained within 45 days prior to study entry\n* HIV RNA \\< 20 copies/ml for ≥12 weeks (1 blip of \\< 500 copies/ml will be permitted)\n* Absolute neutrophil count ≥ 1000 cells/mm3\n\nExclusion Criteria:\n\n* Initiation of ART during acute/early HIV infection (within 6 months of HIV seroconversion)\n* 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)\n* Use of antibiotics 60 days prior to the study entry\n* Use of investigational therapies or vaccines 60 days prior to the study entry\n* Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry\n* Cirrhosis, inflammatory bowel disease, total colectomy, colon or rectal anastomosis, bowel resection, or current colostomy\n* Diabetes mellitus\n* Any episode of acute or persistent diarrhea within 60 days prior to study entry\n* 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).'}, 'identificationModule': {'nctId': 'NCT03329560', 'briefTitle': 'Safety of FMT Using Oral Encapsulated PRIM-DJ2727 in HIV', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Safety of Fecal Microbiota Transplant Using Oral Encapsulated PRIM-DJ2727 in HIV-infected Persons on Antiretroviral Therapy', 'orgStudyIdInfo': {'id': 'HSC-MS-17-0782'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral fecal microbiota transplantation', 'description': '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.', 'interventionNames': ['Biological: Oral fecal microbiota transplantation']}], 'interventions': [{'name': 'Oral fecal microbiota transplantation', 'type': 'BIOLOGICAL', 'otherNames': ['PRIM-DJ2727'], 'description': '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.', 'armGroupLabels': ['Oral fecal microbiota transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Thomas Street Health Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Netanya S Utay, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Netanya Utay', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}