Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-03-02 @ 4:00 PM
Study NCT ID:
NCT04406727
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-24
First Post:
2020-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000630912', 'term': 'UB-421'}, {'id': 'D044966', 'term': 'Anti-Retroviral Agents'}], 'ancestors': [{'id': 'D000998', 'term': 'Antiviral Agents'}, {'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-21', 'studyFirstSubmitDate': '2020-05-22', 'studyFirstSubmitQcDate': '2020-05-22', 'lastUpdatePostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HIV-1 RNA viral load between 2 arms', 'timeFrame': '14 Days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV-1 Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this phase III study is to evaluate the efficacy between treatments (UB-421 Arm vs. Placebo Arm) by measuring the proportion of subjects with reduction in HIV-1 RNA viral load.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. HIV-1 seropositive\n2. Have a history of at least 6 months on antiretroviral treatment\n3. Receiving a stable combination antiretroviral therapy (ART) for at least 8 weeks before Screening\n\nExclusion Criteria:\n\n1. Subjects with HBsAg positive or HCV antibody positive, along with ALT or AST \\> 4 x upper limit of normal (ULN)\n2. Females who are pregnant\n3. Any vaccination within 2 weeks prior to the Screening\n4. Any prior exposure to UB-421'}, 'identificationModule': {'nctId': 'NCT04406727', 'briefTitle': 'UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'United BioPharma'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Phase 3 Trial With UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection', 'orgStudyIdInfo': {'id': 'UBP-A308-HIV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UB-421', 'description': '2-arm Comparison Phase: UB-421(25 mg/kg, every 2 weeks) in combination with ARV\n\nSingle-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR).', 'interventionNames': ['Biological: UB-421', 'Other: Antiretroviral (ARV)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo', 'description': '2-arm Comparison Phase: Placebo in combination with ARV\n\nSingle-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR).', 'interventionNames': ['Other: Antiretroviral (ARV)']}], 'interventions': [{'name': 'UB-421', 'type': 'BIOLOGICAL', 'description': 'UB-421 in combination with their ARV', 'armGroupLabels': ['UB-421']}, {'name': 'Antiretroviral (ARV)', 'type': 'OTHER', 'description': 'Antiretroviral (ARV)', 'armGroupLabels': ['Placebo', 'UB-421']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Linda Shih', 'role': 'CONTACT', 'email': 'linda.shih@unitedbiopharma.com', 'phone': '+886-3-668-4800', 'phoneExt': '3204'}, {'name': 'Zhonghao Shi', 'role': 'CONTACT', 'email': 'zhonghao.shi@unitedbiopharma.com', 'phone': '+886-3-668-4800', 'phoneExt': '3201'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United BioPharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}