Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-03-04 @ 11:54 PM
Study NCT ID:
NCT03663920
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2018-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HIV Infection and Risk Related Coinfections/Comorbidities in Indonesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018450', 'term': 'Disease Progression'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "Subjects or subject's parent must be willing to allow storage plasma and buffy coat at baseline visit and plasma at every follow up visit. All samples will be stored at the INA-RESPOND Reference laboratory and at each site"}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4336}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-09', 'studyFirstSubmitDate': '2018-01-04', 'studyFirstSubmitQcDate': '2018-09-07', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of participants achieving viral suppression (HIV RNA Viral Load <1000 copies/mL) in Indonesia.', 'timeFrame': 'From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years', 'description': 'Incidence of participants achieving viral suppression with HIV RNA Viral Load \\<1000 copies/mL.'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants with HIV RNA Viral Load <1000 copies/mL at baseline and every six-monthly follow-up visit.', 'timeFrame': 'From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years', 'description': 'Proportion of participants with HIV RNA Viral Load \\<1000 copies/mL at baseline and every six-monthly follow-up visit as virological outcomes'}, {'measure': 'Mean change in CD4+ cell count from baseline and every six-monthly follow-up visit.', 'timeFrame': 'From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years', 'description': 'Evaluate the immunologic response by the CD4 measurement from baseline (Mean change in CD4+ cell count) and every six-monthly follow-up visit as immunological outcomes'}, {'measure': 'Proportion of AIDS defining illnesses at baseline and every six-monthly follow-up visit.', 'timeFrame': 'From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years', 'description': 'Proportion of AIDS defining illnesses from baseline and every six-monthly follow-up visit as disease progression outcomes'}, {'measure': 'Proportion of serious non-AIDS disease at baseline and every six-monthly follow-up visit.', 'timeFrame': 'From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years', 'description': 'Proportion of serious non-AIDS disease from baseline and every six-monthly follow-up visit as disease progression outcomes'}, {'measure': 'Incidence of AIDS-related deaths at baseline and every six-monthly follow-up visit.', 'timeFrame': 'From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years', 'description': 'Incidence of AIDS-related deaths at baseline and every six-monthly follow-up visit as the mortality outcomes'}, {'measure': 'Incidence of non-AIDS-related deaths at baseline and every six-monthly follow-up visit.', 'timeFrame': 'From date of enrollment until the date of 36 months of follow-up study visit, lost to follow-up or death, whichever came first, assessed up to 3 years', 'description': 'Incidence of non-AIDS-related deaths at baseline and every six-monthly follow-up visit as the mortality outcomes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Viral Load', 'CD4', 'Mortality', 'Disease Progression'], 'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '39833697', 'type': 'DERIVED', 'citation': 'Merati TP, Yunihastuti E, Wisaksana R, Kurniati N, Arlinda D, Karyana M, Susanto NH, Lokida D, Kosasih H, Diana A, Bang LE, Setiyaningrum M, Amin DM, Eppy E, Cahyawati WASN, Danudirgo EW, Darmaja IMG, Farhanah N, Gunawan CA, Hadi U, Jamil KF, Katu S, Kembaren T, Kosa IGR, Norosingomurti DL, Purnama A, Laksanawati IS, Rusli A, Somia IKA, Subronto YW, Toruan IL, Ridzon R, Liang CJ, Neal AT, Chen RY; INA-PROACTIVE Study Group. A prospective observational cohort study of HIV infection in Indonesia: baseline characteristics and one-year mortality. BMC Infect Dis. 2025 Jan 20;25(1):87. doi: 10.1186/s12879-024-10354-8.'}]}, 'descriptionModule': {'briefSummary': 'INA-PROACTIVE is a multicenter, prospective, observational cohort study of HIV positive antiretroviral-naïve and treatment-experienced individuals. No investigational treatment or intervention will be used by this study. All participants will be managed according to the Indonesian HIV/AIDS Treatment Guideline and/or the Standard of Care (SoC) in local clinical setting, with the addition of rapid HIV viral load, CD4 cell count and syphilis testing.', 'detailedDescription': "This study will accept participants meeting the eligibility criteria and data will be collected at baseline visit and 6-monthly regular follow up visits for 3 years (at month 6, 12, 18, 24, 30, and 36). The study will allow a ± 3-month window period for each scheduled regular follow up visit to minimize loss to follow up. Additional follow up data may be collected between regular follow up visits on certain participants who meet the additional follow up criteria.\n\nDuring each visit, data collection will include socio-demographics, family history, past and current medical history, clinical assessments, laboratory and/or other supporting diagnosis examination. Blood specimens from each study visits will be collected for future research on immune function, pathogenesis, and genetics or genomics of HIV and risk related coinfections/comorbidities. The stored specimens will be investigated during the study and/or after the study completion.\n\nBased on the highest number of HIV cases in hospitals from the National HIV/AIDS Control Program (MoHRI, 2016), 33 hospitals were identified as the proposed study sites (Appendix B). Ten hospitals are established INA-RESPOND's study sites. They are Dr. Cipto Mangunkusumo Hospital, Prof. Dr. Sulianti Saroso Infectious Diseases Hospital, and Persahabatan Hospital in Jakarta; Dr. Hasan Sadikin Hospital, Bandung; Dr. Kariadi Hospital, Semarang; Dr. Sardjito Hospital, Yogyakarta; Dr. Soetomo Hospital, Surabaya; Sanglah Hospital, Denpasar; Dr. Wahidin Sudirohusodo Hospital, Makassar; and Kab. Tangerang Hospital, Banten.\n\nTen additional new study sites will be selected from the list (Appendix B) and the INA-RESPOND team will conduct site assessments to determine their willingness and readiness to be INA-PROACTIVE study sites. If site activation is lagging, other hospitals not on the list can also be assessed as a potential study sites.\n\nThe total 20 study sites will be activated gradually based on their readiness within 2 years (12 sites on year-1 and additional 8 sites on year-2). It is expected that the additional new sites will expand the network, increase participants' recruitment, and will be able to represent Indonesian situation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This is a prospective descriptive study that aims to estimate the characteristics, including among death cases, of people living with HIV in Indonesia. The study population will include people living with HIV at any age, any sex/gender, any HIV-affected key populations, whether ART-naïve or treatment-experienced in Indonesia. To get an estimation with 95% confidence interval (95% CI) that represents the true value in population. We calculated the minimum death cases need to be observed using the proportion of female HIV patients among death cases in Indonesia in 2016 (31%) and case fatality rate for HIV patients in Indonesia, 2016 (1.11%). The minimum number of death to be observed and HIV patients to be enrolled', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. HIV positive by the Standard of Care.\n2. Documented informed consent for participants' ≥18 years old or informed consent by parents/legally accepted representative (LAR) or assent for minor participants prior to study procedures.\n3. Willing to comply with the study procedures.\n4. Agrees to the collection and storage of specimens for use in future research on immune function, pathogenesis, and/or genetics/genomics of HIV and opportunistic infections. (The participant may decline participation in genetic or genomics research and will still be eligible for the study).\n\nExclusion criteria:\n\n1. Plans to move away to an area where the participant will not be able to complete the study visits in 3 years.\n2. Is currently imprisoned."}, 'identificationModule': {'nctId': 'NCT03663920', 'acronym': 'INAPROACTIVE', 'briefTitle': 'HIV Infection and Risk Related Coinfections/Comorbidities in Indonesia', 'organization': {'class': 'OTHER', 'fullName': 'Ina-Respond'}, 'officialTitle': 'A Prospective Observational Cohort Study on HIV Infection and Risk Related Coinfections/Comorbidities in Indonesia', 'orgStudyIdInfo': {'id': 'INA104'}, 'secondaryIdInfos': [{'id': 'U1111-1263-2484', 'type': 'OTHER', 'domain': 'WHO UTN Number'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80114', 'city': 'Denpasar', 'state': 'Bali', 'country': 'Indonesia', 'facility': 'Site 520: University of Udayana/Sanglah Hospital', 'geoPoint': {'lat': -8.65, 'lon': 115.21667}}, {'zip': '50244', 'city': 'Semarang', 'state': 'Central of Java', 'country': 'Indonesia', 'facility': 'Site 560: University of Diponegoro/ Dr. Kariadi Hospital', 'geoPoint': {'lat': -6.99306, 'lon': 110.42083}}, {'zip': '10430', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Site 530: University of Indonesia/ Dr. Cipto Mangunkusumo Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '14340', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Site 540: Penyakit Infeksi Sulianti Saroso Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '14340', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Site 590: Persahabatan Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '75123', 'city': 'Samarinda', 'state': 'East Kalimantan', 'country': 'Indonesia', 'facility': 'Site 660 RSUD Abdul Wahab Sjahranie', 'geoPoint': {'lat': -0.49167, 'lon': 117.14583}}, {'zip': '86113', 'city': 'Maumere', 'state': 'East Nusa Tenggara', 'country': 'Indonesia', 'facility': 'Site 700 - RSUD Dr.TC Hillers', 'geoPoint': {'lat': -8.6199, 'lon': 122.2111}}, {'zip': '60286', 'city': 'Surabaya', 'state': 'East of Java', 'country': 'Indonesia', 'facility': 'Site 570: University of Airlangga/ Dr. Soetomo Hospital', 'geoPoint': {'lat': -7.24917, 'lon': 112.75083}}, {'zip': '20136', 'city': 'Medan', 'state': 'North Sumatra', 'country': 'Indonesia', 'facility': 'Site 600 : Adam Malik Hospital', 'geoPoint': {'lat': 3.58333, 'lon': 98.66667}}, {'city': 'Batam', 'state': 'Riau Islands', 'country': 'Indonesia', 'facility': 'Site 650: Budi Kemuliaan Hospital', 'geoPoint': {'lat': 1.128, 'lon': 103.96493}}, {'zip': '70125', 'city': 'Banjarmasin', 'state': 'South Kalimantan', 'country': 'Indonesia', 'facility': 'Site 630: M. Ansari Saleh Hospital', 'geoPoint': {'lat': -3.31987, 'lon': 114.59075}}, {'zip': '99351', 'city': 'Jayapura', 'state': 'Special Region of Papua', 'country': 'Indonesia', 'facility': 'Site 690 - RSUD Abepura', 'geoPoint': {'lat': -2.53371, 'lon': 140.71813}}, {'zip': '40161', 'city': 'Bandung', 'state': 'West Java', 'country': 'Indonesia', 'facility': 'Site 510: University of Padjajaran/ Dr. Hasan Sadikin Hospital', 'geoPoint': {'lat': -6.92222, 'lon': 107.60694}}, {'zip': '15111', 'city': 'Tangerang', 'state': 'West Java', 'country': 'Indonesia', 'facility': 'Site 610 : RSU Kabupaten Tangerang'}, {'zip': '78111', 'city': 'Pontianak', 'state': 'West Kalimantan', 'country': 'Indonesia', 'facility': 'Site 680 - RSUD dr Soedarso', 'geoPoint': {'lat': -0.03194, 'lon': 109.325}}, {'zip': '24415', 'city': 'Banda Aceh', 'country': 'Indonesia', 'facility': 'Site 670 - RSUD Dr. Zainoel Abidin', 'geoPoint': {'lat': 5.54167, 'lon': 95.33333}}, {'zip': '10440', 'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Site 640: St. Carolus Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '90245', 'city': 'Makassar', 'country': 'Indonesia', 'facility': 'Site 550: University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital', 'geoPoint': {'lat': -5.14861, 'lon': 119.43194}}, {'zip': '55284', 'city': 'Yogyakarta', 'country': 'Indonesia', 'facility': 'Site 580: University of Gadjah Mada/ Dr. Sardjito Hospital', 'geoPoint': {'lat': -7.80139, 'lon': 110.36472}}], 'overallOfficials': [{'name': 'Prof. Dr. dr. Tuti Parwati Merati, Sp.PD.KPTI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine Udayana University-Sanglah Hospital, Denpasar'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ina-Respond', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}