Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2025-12-31 @ 9:39 PM
Study NCT ID:
NCT05224492
Status:
UNKNOWN
Last Update Posted:
2022-02-07
First Post:
2022-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sulforaphane Use to Effect Inflammatory and Metabolic Changes in Virally Suppressed HIV Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C016766', 'term': 'sulforaphane'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-02-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-09-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-03', 'studyFirstSubmitDate': '2022-02-01', 'studyFirstSubmitQcDate': '2022-02-03', 'lastUpdatePostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lipids', 'timeFrame': '4 months', 'description': 'Triglycerides, Cholesterol'}, {'measure': 'Inflammatory Markers', 'timeFrame': '4 months', 'description': 'CRP'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'Assess the effects of Sulforaphane supplementation in HIV patients that have achieved viral suppression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV patients on active treatment who have a suppressed viral load and have been virally suppressed for 6 months or more.\n* BMI increase of 10% or more since initiation of HIV treatment over a year period.\n* BMI equal to or greater than 30.\n* 18-85 years of age.\n\nExclusion Criteria:\n\n* Cancer\n* Pregnancy or breastfeeding\n* Intolerance to cruciferous vegetables\n* Intolerance to sulforaphane\n* Gluten Intolerance\n* Creatinine \\> 1.3 mg/dL\n* GFR \\< 60\n* AST or ALT \\> 1.5 times upper limit of normal.\n* White cell count \\< 2000 cells per ml.\n* Hemoglobin \\< 10.5 g/dL.\n* Platelet count \\< 140,000 per ml.'}, 'identificationModule': {'nctId': 'NCT05224492', 'briefTitle': 'Sulforaphane Use to Effect Inflammatory and Metabolic Changes in Virally Suppressed HIV Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sunshine Specialty Health Care'}, 'officialTitle': 'Sulforaphane Use to Effect Inflammatory and Metabolic Changes in Virally Suppressed HIV Patients', 'orgStudyIdInfo': {'id': 'SSHC1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sulforaphane Group', 'interventionNames': ['Drug: Sulforaphane']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Sulforaphane', 'type': 'DRUG', 'description': '40 mg of Sulforaphane powder once daily.', 'armGroupLabels': ['Sulforaphane Group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Johannah G Katz', 'role': 'CONTACT', 'email': 'Johannahfgiron@gmail.com', 'phone': '4074894750'}, {'name': 'Jose A. Giron, MD', 'role': 'CONTACT', 'email': 'Joseoidc@aol.com', 'phone': '4078885980'}], 'overallOfficials': [{'name': 'Jose A. Giron, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunshine Specialty Health Care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunshine Specialty Health Care', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}