Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-30 @ 8:20 AM
Study NCT ID:
NCT03009032
Status:
COMPLETED
Last Update Posted:
2017-08-01
First Post:
2016-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Synbiotics in Advanced HIV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-30', 'studyFirstSubmitDate': '2016-12-28', 'studyFirstSubmitQcDate': '2016-12-30', 'lastUpdatePostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': 'From baseline through week 48'}, {'measure': 'Changes in CD4+ T cell counts/uL', 'timeFrame': 'From baseline through week 48'}, {'measure': 'Changes in CD8+ T cell counts/uL', 'timeFrame': 'From baseline through week 48'}, {'measure': 'Changes in CD4/CD8 ratio', 'timeFrame': 'From baseline through week 48'}], 'secondaryOutcomes': [{'measure': 'Microbiota composition: alpha-diversity', 'timeFrame': 'From baseline through week 48'}, {'measure': 'Microbiota composition: Unifrac distances', 'timeFrame': 'From baseline through week 48'}, {'measure': 'Microbiota composition: Canberra distances', 'timeFrame': 'From baseline through week 48'}, {'measure': 'Changes in plasma soluble CD14 levels', 'timeFrame': 'From baseline through week 48'}, {'measure': 'Changes in plasma hs-CRP levels', 'timeFrame': 'From baseline through week 48'}, {'measure': 'Changes in plasma IFABP levels', 'timeFrame': 'From baseline through week 48'}, {'measure': 'Changes in plasma lipoteichoic acid levels', 'timeFrame': 'From baseline through week 48'}, {'measure': 'Changes in plasma kynurenine/tryptophan ratio', 'timeFrame': 'From baseline through week 48'}, {'measure': 'Changes in percentage of HLADR+/CD38+ T cells', 'timeFrame': 'From baseline through week 48'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'immunologic recovery', 'microbiota', 'prebiotics', 'probiotics', 'synbiotics'], 'conditions': ['HIV Infection Asymptomatic']}, 'descriptionModule': {'briefSummary': 'Late diagnosed HIV-infected subjects show impaired immunological recovery resulting in a greater risk of clinical progression. Gut bacteria metabolism appears to impact immune recovery in HIV-infected subjects, and while nutritional interventions with prebiotics and probiotics seem to exert immunological effects, the clinical implications in this key population remain unknown. This is a pilot multicenter randomized placebo-controlled, double blind clinical trial in HIV-infected ART-naive subjects with \\<350 CD4 T cells/mm3 or AIDS. Participants will be randomized (1:1) to either the synbiotic nutritional supplement PMT25341 or placebo for 48 weeks, each in combination with first-line ART. Primary outcomes will be safety and immunological recovery. Secondary outcomes will include changes in fecal microbiota structure and plasma inflammatory markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-infected ART-naive subjects with \\<350 CD4 T cells/mm3 or AIDS\n* Initiating ART with any first-line regimen recommended in the Spanish GESIDA National Guidelines\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Pregnancy\n* Type 1 or 2 diabetes\n* End-stage renal disease\n* Lactose intolerance\n* Use of immunomodulatory drugs\n* Neutrophil count \\<750cells/uL'}, 'identificationModule': {'nctId': 'NCT03009032', 'acronym': 'PROMALTIA', 'briefTitle': 'Synbiotics in Advanced HIV Infection', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal'}, 'officialTitle': 'Immunological Effects of an Immunomodulatory Synbiotic Intervention at Advanced HIV Disease', 'orgStudyIdInfo': {'id': '14/016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PMT25341', 'description': 'A mixture of prebiotics, probiotics, oligonutrients, essential aminoacids, omega-3 fatty acids', 'interventionNames': ['Dietary Supplement: PMT25341']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLACEBO', 'description': 'Lactose', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'PMT25341', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['PMT25341']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Lactose', 'armGroupLabels': ['PLACEBO']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital San Carlos, Madrid', 'class': 'OTHER'}, {'name': 'Hospital Universitario 12 de Octubre', 'class': 'OTHER'}, {'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}, {'name': 'Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz', 'class': 'OTHER'}, {'name': 'Hospital San Pedro de Logroño', 'class': 'OTHER'}, {'name': 'Hospital del Mar', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Sergio Serrano-Villar', 'investigatorAffiliation': 'Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal'}}}}