Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-22 @ 12:51 PM
Study NCT ID:
NCT04091932
Status:
UNKNOWN
Last Update Posted:
2019-09-20
First Post:
2019-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of PD-1 Inhibitor in AIDS-associated PML
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007968', 'term': 'Leukoencephalopathy, Progressive Multifocal'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D018792', 'term': 'Encephalitis, Viral'}, {'id': 'D020805', 'term': 'Central Nervous System Viral Diseases'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000069544', 'term': 'Infectious Encephalitis'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D027601', 'term': 'Polyomavirus Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D000082082', 'term': 'Immune Checkpoint Inhibitors'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000074322', 'term': 'Antineoplastic Agents, Immunological'}, {'id': 'D000970', 'term': 'Antineoplastic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-18', 'studyFirstSubmitDate': '2019-09-15', 'studyFirstSubmitQcDate': '2019-09-15', 'lastUpdatePostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the rate of non-progressors and recovers of AIDS patients with PML in 6 months after receiving PD-1 inhibitor', 'timeFrame': '6 months', 'description': 'With treatment of Pembrolizumab for 6 months, we will evaluate the rate of non-progressors and recovers of AIDS patients with PML'}, {'measure': 'the rate of non-progressors and recovers of AIDS patients with PML in 12 months after receiving PD-1 inhibitor', 'timeFrame': '12 months', 'description': 'With treatment of Pembrolizumab for 12 months, we will evaluate the rate of non-progressors and recovers of AIDS patients with PML'}], 'secondaryOutcomes': [{'measure': 'the negative conversion rate of John Cunningham virus (JCV) in cerebrospinal fluid，blood and urine in patients receiving Pembrolizumab.', 'timeFrame': '3 months', 'description': 'With treatment of Pembrolizumab for 3 months, we will evaluate the negative conversion rate of JCV in cerebrospinal fluid，blood and urine'}, {'measure': 'Side effects associated with Pembrolizumab', 'timeFrame': '12 months', 'description': 'To investigate the safety of Pembrolizumab in HIV patients'}, {'measure': 'The rate of patients with decreased HIV viral reservoir', 'timeFrame': '12 months', 'description': 'To investigate the rate of patients with decreased HIV viral reservoir'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PD-1 inhibitor', 'Pembrolizumab', 'Progressive Multifocal Leukoencephalopathy', 'AIDS'], 'conditions': ['Progressive Multifocal Leukoencephalopathy', 'AIDS']}, 'descriptionModule': {'briefSummary': 'PD-1 inhibitor （Pembrolizumab, 2mg/kg weight, once per 4 weeks and 3 times of medication usage）treatment on AIDS patients with progressive multifocal leukoencephalopathy.', 'detailedDescription': 'This is a one-center, single-arm and prospective study, planing recruiting 10 AIDS-associated PML patients. All patients will receive PD-1 inhibitor (Pembrolizumab) for 12 weeks, and the dose for each time is 2 mg per kg/weight, and the frequency is once per 4 weeks. The effect and safety of Pembrolizumab on AIDS-associated PML will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 18-65\n2. Diagnosed of HIV by lab confirmation\n3. Diagnosed of PML by diplomatic radiologists through brain MRI or by brain biopsy once there are some concerns on radiologic diagnosis.\n4. agree to sign the consent\n5. agree to use contraception measures during 4 weeks before to 6 months after this study\n\nExclusion Criteria:\n\n1. Pregnancy or lactating women or planing birth during this study\n2. Anticipated bad treatment compliance\n3. Within 6 months before joining this study, receive other immunosuppressors, immunomodulators or cytotoxic drugs (glucocorticoid is allowed)；\n4. With neutrophil\\<1000/mm3 or platelet\\<75000/mm3 or allergic to PD-1 inhibitor 5）With severe basic diseases in heart, brain, lung, liver, kidney\n\n6\\) disagree to sign the consent'}, 'identificationModule': {'nctId': 'NCT04091932', 'acronym': 'TPAP', 'briefTitle': 'Treatment of PD-1 Inhibitor in AIDS-associated PML', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Zhejiang University'}, 'officialTitle': 'The Effect and Safety of Programmed Cell Death Protein 1 (PD-1) Inhibitor on AIDS Patients With Progressive Multifocal Leukoencephalopathy (PML): A One-center, Single-arm and Prospective Study', 'orgStudyIdInfo': {'id': '2019-57'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pembrolizumab treatment', 'description': 'Pembrolizumab dosage form:100mg/4ml dosage:2mg/kg weight frequency: once per 4 weeks duration:12 weeks', 'interventionNames': ['Drug: Pembrolizumab']}], 'interventions': [{'name': 'Pembrolizumab', 'type': 'DRUG', 'otherNames': ['PD-1 inhibitor'], 'description': 'Monthly usage of Pembrolizumab (2mg/kg weight) for 3 months.', 'armGroupLabels': ['Pembrolizumab treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junwei Su, MD', 'role': 'CONTACT', 'email': 'zjusujunwei@163.com', 'phone': '13777441318'}], 'facility': 'the first affiliated hospital of Zhejiang university school of medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Biao Zhu, PhD', 'role': 'CONTACT', 'email': 'zhubiao1207@zju.edu.cn', 'phone': '13906535457'}, {'name': 'Junwei Su, MD', 'role': 'CONTACT', 'email': '1514031@zju.edu.cn', 'phone': '13777441318'}], 'overallOfficials': [{'name': 'Biao Zhu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}