Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT04140461
Status:
UNKNOWN
Last Update Posted:
2019-10-29
First Post:
2019-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AmB Dose for Cryptococcal Meningitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016919', 'term': 'Meningitis, Cryptococcal'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D016921', 'term': 'Meningitis, Fungal'}, {'id': 'D020314', 'term': 'Central Nervous System Fungal Infections'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003453', 'term': 'Cryptococcosis'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'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': 'D000666', 'term': 'Amphotericin B'}, {'id': 'D023241', 'term': 'Antiretroviral Therapy, Highly Active'}, {'id': 'D005437', 'term': 'Flucytosine'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004359', 'term': 'Drug Therapy, Combination'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003596', 'term': 'Cytosine'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-01-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-25', 'studyFirstSubmitDate': '2019-10-24', 'studyFirstSubmitQcDate': '2019-10-24', 'lastUpdatePostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Treatment-Emergent Adverse Events', 'timeFrame': '12 weeks after randomization', 'description': 'All the adverse events occurred after randomization'}], 'primaryOutcomes': [{'measure': 'Number of subjects died at weeks 48', 'timeFrame': '48 weeks after randomization', 'description': 'Mortality in intent to treat population'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with CSF culture positive for Cryptococcus at weeks 2', 'timeFrame': '2 weeks after randomization', 'description': 'Antifungal Activity'}, {'measure': 'Number of subjects with disability at weeks 48', 'timeFrame': '48 weeks after randomization', 'description': 'Disability rate in intent to treat population'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV infection', 'Cryptococcal Meningitis', 'Amphotericin B'], 'conditions': ['Cryptococcal Meningitis', 'HIV Infections']}, 'descriptionModule': {'briefSummary': 'Cryptococcal meningitis (CM) is one of the leading opportunistic infections and one of the most common causes of death in AIDS patients.\n\nAmphotericin B (AmB) is the corner stone in CM treatment. The effect of AmB was dose-dependent. Recent retrospective study indicated that longer duration rather than higher dose of AmB is necessary to reduce the mortality of CM. We aimed to explore the efficacy and safety of small dose but longer duration of AmB for the treatment of HIV-associated CM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed HIV infection\n* Naive to antiretroviral therapy\n* Cryptococcal antigen, smear or culture positive in cerebrospinal fluid\n* Agree to participate the study\n\nExclusion Criteria:\n\n* Having receiving antifungal treatment for ≥3 days\n* ALT or AST \\> 5\\* upper limit of detection (ULD), or neutrophil\\< 0.5\\*10E9 cells/L, or hemoglobin \\< 90g/L or platelet \\<50\\*10E9/L or serum creatinine \\> ULD\n* Pregnancy or breastfeeding\n* Concomitant medications that are contraindicated with any research drug\n* Any other contraindications for using amphotericin B or 5FC\n* Inability to follow-up as accessed by the investigator'}, 'identificationModule': {'nctId': 'NCT04140461', 'briefTitle': 'AmB Dose for Cryptococcal Meningitis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Shanghai Public Health Clinical Center'}, 'officialTitle': 'Antifungal Treatment of Cryptococcal Meningitis', 'orgStudyIdInfo': {'id': 'AMBDOSE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trial', 'description': 'Amphotericin B 0.5 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 4 weeks', 'interventionNames': ['Drug: Amphotericin B', 'Drug: Flucytosine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Amphotericin B 0.7 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 2 weeks', 'interventionNames': ['Drug: Amphotericin B', 'Drug: Flucytosine']}], 'interventions': [{'name': 'Amphotericin B', 'type': 'DRUG', 'otherNames': ['Antiretroviral therapy'], 'description': 'The trial group and the control group received AmB 0.5mg/kg for 4 weeks and 0.7mg/kg for 2 weeks respectively.', 'armGroupLabels': ['Control', 'Trial']}, {'name': 'Flucytosine', 'type': 'DRUG', 'description': 'The trial group and the control group received 100mg/kg for 4 weeks and for 2 weeks respectively.', 'armGroupLabels': ['Control', 'Trial']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201508', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Public Health Clinical Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jun Chen, M.D', 'role': 'CONTACT', 'email': 'qtchenjun@163.com', 'phone': '+86-21-37990333', 'phoneExt': '3222'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Public Health Clinical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant of the department', 'investigatorFullName': 'Jun Chen', 'investigatorAffiliation': 'Shanghai Public Health Clinical Center'}}}}