Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-02-20 @ 1:43 PM
Study NCT ID:
NCT06507059
Status:
RECRUITING
Last Update Posted:
2024-08-23
First Post:
2024-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C584914', 'term': 'cabotegravir'}, {'id': 'D000068696', 'term': 'Rilpivirine'}, {'id': 'C000712547', 'term': 'cabotegravir, rilpivirine drug combination'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'RECRUITING', 'startDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-21', 'studyFirstSubmitDate': '2024-07-07', 'studyFirstSubmitQcDate': '2024-07-11', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Achieved ART trough level assessment', 'timeFrame': 'Week 52', 'description': 'Use liquid chromatography- mass spectrometry to determine rilpivirine and cabotegravir concentrations in stored remaining plasma specimen collected at each visit'}, {'measure': 'Change of acceptability score', 'timeFrame': 'Day1 (post-injection), week 24, 52 for the immediate LA treatment group; week 24 (post-injection), and week 52 for the delayed switch to LA group.', 'description': 'Acceptability assessment for long-acting injectable antiretrovirals'}, {'measure': 'Delayed injections', 'timeFrame': 'up to week 52', 'description': 'Percentage of delayed injections (\\>7 days after the target visit)'}, {'measure': 'HIV-1 RNA <50 copies/mL', 'timeFrame': 'Week 72, week 96', 'description': 'Percentage of study participants with plasma HIV-1 RNA \\<50 copies/mL'}], 'primaryOutcomes': [{'measure': 'HIV-1 RNA <200 copies/mL', 'timeFrame': 'Week 24', 'description': 'Percentage of study participants with plasma HIV-1 RNA \\<200 copies/mL at week 24'}], 'secondaryOutcomes': [{'measure': 'HIV-1 RNA <50 copies/mL', 'timeFrame': 'Week 24, week 52', 'description': 'Percentage of study participants with plasma HIV-1 RNA \\<50 copies/mL at week 24, 52'}, {'measure': 'HIV-1 RNA <200 copies/mL', 'timeFrame': 'Week 52', 'description': 'Percentage of study participants with plasma HIV-1 RNA \\<200 copies/mL at week 52'}, {'measure': 'Change of plasma HIV-1 viral load', 'timeFrame': 'Week 24, week 52', 'description': 'Change of plasma HIV-1 RNA at week 24, 52'}, {'measure': 'Change of CD4 count', 'timeFrame': 'Week 24, week 52', 'description': 'Change of CD4 count at week 24, 52'}, {'measure': 'Occurrence of HIV and non-HIV related conditions', 'timeFrame': 'Week 24, week 52', 'description': 'Percentage of study participants with HIV and non-HIV related conditions occurrence'}, {'measure': 'Lost F/U rate', 'timeFrame': 'up to week 96', 'description': 'Lost follow-up rate at every target visit'}, {'measure': 'Usage of outreach drug delivery service', 'timeFrame': 'up to week 52', 'description': 'Percentage of study participants who use the outreach drug delivery service'}, {'measure': 'Resistant variant emergence', 'timeFrame': 'Week 24, week 52', 'description': 'Resistant variant emergence detection if HIV-1 viral load ≥200 copies/mL'}, {'measure': 'Adverse events', 'timeFrame': 'Week 24, week 52', 'description': 'Incidence and severity of adverse events (AEs)'}, {'measure': 'Discontinuation due to AEs', 'timeFrame': 'Week 24, week 52', 'description': 'Discontinuation due to AEs at week 24, 52'}, {'measure': 'Change of depression score', 'timeFrame': 'Week 24, week 52', 'description': 'Change of depression score at week 24, 52'}, {'measure': 'Change of self-stigma score', 'timeFrame': 'Week 24, week 52', 'description': 'Change of self-stigma score at week 24, 52'}, {'measure': 'Change of metabolic parameters', 'timeFrame': 'Week 24, week 52', 'description': 'Change of metabolic parameters (body weight, BMI) at week 24, 52'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV-1, non-adherence'], 'conditions': ['HIV-1-infection', 'Non-Adherence, Medication']}, 'descriptionModule': {'briefSummary': 'This study aims to determine whether people living with HIV (PLHIV) with suboptimal medical adherence can achieve better viral suppression with long-acting antiretrovirals (LA) compared to all-oral antiretrovirals.', 'detailedDescription': 'This is an open-label, multi-center, randomized, active-controlled, superiority trial on 40 adult subjects who had been diagnosed to have HIV infection for at least 12 months before enrollment but with suboptimal viral suppression despite antiretroviral treatment (ART), with the latest HIV-1 viral load ≥ 200 copies/mL. Participants\' eligibility will be assessed through a review of their medical records, and individuals with established resistance to cabotegravir or rilpivirine will be excluded. Enrolled participants will then be randomized 1:1 to either "Delayed Switch to LA Treatment Group" or "Immediate LA Treatment Group" on enrollment. The "Delayed Switch to LA Treatment Group" will also switch to LA on week 24. The proportion of participants with HIV-1 RNA \\<200 copies/mL at week 24 in the two study groups will be compared. Psychologic assessments including self-stigma and depression assessment will also be performed on day1, at week 24 and week 52.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing to sign the written informed consent form for male and female participants aged 18 and above.\n* At the time of enrollment, diagnosed with HIV infection for a minimum of 12 months.\n* Under oral antiretroviral treatment (ART), which can be irregular or interrupted, with the most recent viral load ≥ 200 copies/mL.\n* Body weight ≥ 35Kg.\n* Willing to maintain contact with the research team throughout the study (provide accurate and reachable phone numbers, social accounts like Line, or reliable contact information of family or friends).\n* Willing to receive gluteal (buttocks) drug injections.\n* Willing to transition back to oral medication or follow the recommended treatment prescription according to the then-current national treatment guidelines after discontinuation of long-acting injectable drugs.\n\nExclusion Criteria:\n\n* For those currently undergoing oral antiretroviral therapy, who have started or restarted oral ART for less than six consecutive months before screening.\n* Previously undergone HIV drug resistance testing and known to have resistance mutations to either cabotegravir or rilpivirine.\n* Unable to commit to maintaining contact with the research team throughout the study.\n* Individuals who cannot receive treatment for hepatitis B during the period of transitioning to long-acting injections, if they are hepatitis B carriers.\n* Individuals with buttock fillers.\n* Women who are planning to become pregnant, pregnant, or currently breastfeeding.'}, 'identificationModule': {'nctId': 'NCT06507059', 'acronym': 'SUPLA', 'briefTitle': 'Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'A Phase 3 Study Comparing Clinical Outcomes in People Living With HIV (PLHIV) With Suboptimal Adherence Treated With Injectable Long-acting Antiretrovirals Versus Oral Antiretrovirals', 'orgStudyIdInfo': {'id': '202301496A3'}, 'secondaryIdInfos': [{'id': 'MOHW113-CDC-C-114-000106', 'type': 'OTHER_GRANT', 'domain': 'Taiwan Centers for Disease Control'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate Long-Acting Injectable Treatment Group', 'description': 'Immediate switch to long-acting injectable antiretrovirals on enrollment', 'interventionNames': ['Drug: cabotegravir/rilpivirine (600mg/ 900mg)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delayed Long-Acting Injectable Treatment Group', 'description': 'Keep on standard all-oral antiretrovirals on enrollment for 24 weeks, then switch to long-acting injectable antiretrovirals', 'interventionNames': ['Drug: Antiretroviral Combinations']}], 'interventions': [{'name': 'cabotegravir/rilpivirine (600mg/ 900mg)', 'type': 'DRUG', 'otherNames': ['Cabenuva'], 'description': 'Immediate switch from oral antiretroviral to long-acting injectables', 'armGroupLabels': ['Immediate Long-Acting Injectable Treatment Group']}, {'name': 'Antiretroviral Combinations', 'type': 'DRUG', 'description': 'Standard all-oral antiretroviral combinations', 'armGroupLabels': ['Delayed Long-Acting Injectable Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '204', 'city': 'Keelung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Nan-Yu Chen', 'role': 'CONTACT', 'email': 'nanyuchen@cgmh.org.tw'}], 'facility': 'Chang Gung Memorial Hospital, Keelung', 'geoPoint': {'lat': 25.13089, 'lon': 121.74094}}, {'zip': '105', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Nan-Yu Chen', 'role': 'CONTACT', 'email': 'nanyuchen@cgmh.org.tw'}], 'facility': 'Chang Gung Memorial Hospital, Taipei', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '330', 'city': 'Taoyuan District', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chien-Yu Cheng, MD, PhD', 'role': 'CONTACT', 'email': 's841060@gm.ym.edu.tw'}], 'facility': 'Taoyuan General Hospital, Ministry of Health and Welfare', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}, {'zip': '333', 'city': 'Taoyuan District', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Nan-Yu Chen', 'role': 'CONTACT', 'email': 'nanyuchen@cgmh.org.tw', 'phone': '+886 3 3281200', 'phoneExt': '8450'}], 'facility': 'Chang Gung Memorial Hospital, Linkou', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'centralContacts': [{'name': 'Nan-Yu Chen, MD, PhD', 'role': 'CONTACT', 'email': 'nanyuchen@cgmh.org.tw', 'phone': '+886 3 3281200', 'phoneExt': '8450'}], 'overallOfficials': [{'name': 'Nan-Yu Chen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Taoyuan General Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}