Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-28 @ 3:29 PM
Study NCT ID:
NCT06337032
Status:
RECRUITING
Last Update Posted:
2025-11-05
First Post:
2024-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013607', 'term': 'Tablets'}, {'id': 'C000613801', 'term': 'emtricitabine tenofovir alafenamide'}, {'id': 'D000069545', 'term': 'Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}, {'id': 'D000069547', 'term': 'Cobicistat'}, {'id': 'C000654125', 'term': 'bictegravir, emtricitabine, tenofovir alafenamide, drug combination'}, {'id': 'D019438', 'term': 'Ritonavir'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D004338', 'term': 'Drug Combinations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2034-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-03', 'studyFirstSubmitDate': '2024-03-22', 'studyFirstSubmitQcDate': '2024-03-22', 'lastUpdatePostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2034-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study', 'timeFrame': 'Up to 9.5 Years'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to 9.5 Years'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV-1-infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.gileadclinicaltrials.com/study?nctid=NCT06337032', 'label': 'Gilead Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for adverse events.\n\nThe primary objectives of this study are as follows:\n\n* To provide continued access to the study drug received in the parent protocol or switch to bictegravir/emtricitabine/tenofovir (B/F/TAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment.\n* To evaluate the safety of the study drug(s) in participants with HIV-1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, GS-US-216-0128, or CO-US-380-5578 and gave consent to study participation.\n\nKey Exclusion Criteria:\n\n* Individuals planning to switch to B/F/TAF on Day 1 cannot have plasma HIV RNA ≥ 50 copies/mL during the last parent study visit prior to screening/Day 1 visit.\n\n * Note: individuals planning to switch after Day 1 must not have plasma HIV RNA ≥ 50 copies/mL (or detectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).\n* Individuals planning to switch to B/F/TAF must not have any ongoing Grade 3 or 4 drug-related AE or clinically relevant Grade 3 or 4 drug-related laboratory abnormality (confirmed on repeat) related to any component of B/F/TAF prior to treatment switch.\n* For those on B/F/TAF or planning to switch to B/F/TAF: previous treatment discontinuation of any component of B/F/TAF due to toxicity or intolerance.\n* For those planning to switch to B/F/TAF: known hypersensitivity to any component of the study drug, its metabolites, or formulation excipients.\n* Ongoing treatment with or prior use of any prohibited medications.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06337032', 'briefTitle': 'A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments', 'orgStudyIdInfo': {'id': 'GS-US-380-6684'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF', 'description': "Participants will continue to take the study drug they were taking in the parent study, emtricitabine/tenofovir alafenamide (F/TAF) along with a 3rd antiretroviral (ARV) agent. The dose of F/TAF will be based on the weight of the participant, ranging between 120/15 mg to 200/25 mg. The dose of F/TAF will be different when given with the boosted and the unboosted 3rd ARV agent: F/TAF (High Dose Tablet) for unboosted 3rd ARV agent; F/TAF (Low Dose Tablet) for the boosted 3rd ARV agent.\n\nParticipants may switch to B/F/TAF, at a dose based on participant's weight.", 'interventionNames': ['Drug: F/TAF (High Dose Tablet)', 'Drug: F/TAF (Low Dose Tablet)', 'Drug: F/TAF (Lowest Dose Tablet)', 'Drug: B/F/TAF (High Dose)', 'Drug: B/F/TAF (Low Dose)', 'Drug: B/F/TAF (High Dose TOS)', 'Drug: 3rd ARV Agent']}, {'type': 'EXPERIMENTAL', 'label': 'Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E/C/F/TAF) or B/F/TAF', 'description': "Participants will continue to take the study drug they were taking in the parent study, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF). The dose of E/C/F/TAF will be based on the weight of the participant, ranging between 90/90/120/6 mg to 150/150/200/10 mg.\n\nParticipants may switch to B/F/TAF at a dose based on participant's weight.", 'interventionNames': ['Drug: E/C/F/TAF', 'Drug: E/C/F/TAF (Low Dose)', 'Drug: B/F/TAF (High Dose)', 'Drug: B/F/TAF (Low Dose)']}, {'type': 'EXPERIMENTAL', 'label': 'Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF', 'description': "Participants will continue to take the following study drugs they were taking in the parent study:\n\n* Cobicistat (COBI) + DRV + NRTI backbone\n* COBI + ATV + NRTI backbone\n* F/TAF + DRV+ COBI\n* F/TAF + ATV+ COBI\n* F/TAF + LPV/r\n* F/TAF + 3rd unboosted agent\n\nThe dose of F/TAF will be based on the weight of the participant, ranging between 15/1.88 mg and 200/25 mg, once daily. Additionally, the dose of COBI will be based on the weight of the participant, ranging between 30 mg and 150 mg, once or twice daily.\n\nParticipants may switch to B/F/TAF at a dose based on participant's weight.", 'interventionNames': ['Drug: F/TAF (High Dose Tablet)', 'Drug: F/TAF (Lowest Dose Tablet)', 'Drug: F/TAF (High Dose TOS)', 'Drug: F/TAF (Low Dose TOS)', 'Drug: F/TAF (Lowest Dose TOS)', 'Drug: Cobicistat (High Dose)', 'Drug: Cobicistat (Low Dose)', 'Drug: Cobicistat (TOS)', 'Drug: B/F/TAF (High Dose)', 'Drug: B/F/TAF (Low Dose)', 'Drug: B/F/TAF (High Dose TOS)', 'Drug: B/F/TAF (Low Dose TOS)', 'Drug: B/F/TAF (Lowest Dose TOS)', 'Drug: 3rd ARV Agent', 'Drug: Nucleos(t)ide reverse transcriptase inhibitors (NRTI)', 'Drug: ATV', 'Drug: DRV', 'Drug: Lopinavir Boosted with ritonavir (LPV/r)']}, {'type': 'EXPERIMENTAL', 'label': 'Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF)', 'description': 'Participants will continue to take the study drug they were taking in the parent study, B/F/TAF. Participants who are diagnosed with HIV-1 infection in parent study CO-US-380-5578 and complete the study drug will continue to take the study drug they were taking in the parent study, B/F/TAF. The dose of B/F/TAF will be based on the weight of the participant.', 'interventionNames': ['Drug: B/F/TAF (High Dose)', 'Drug: B/F/TAF (Low Dose)', 'Drug: B/F/TAF (High Dose TOS)', 'Drug: B/F/TAF (Low Dose TOS)', 'Drug: B/F/TAF (Lowest Dose TOS)']}], 'interventions': [{'name': 'F/TAF (High Dose Tablet)', 'type': 'DRUG', 'otherNames': ['Descovy®'], 'description': '200/25 mg fixed-dose combination (FDC) tablet administered orally', 'armGroupLabels': ['Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF', 'Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF']}, {'name': 'F/TAF (Low Dose Tablet)', 'type': 'DRUG', 'description': '200/10 mg FDC tablet administered orally', 'armGroupLabels': ['Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF']}, {'name': 'F/TAF (Lowest Dose Tablet)', 'type': 'DRUG', 'description': '120/15 mg FDC tablet administered orally', 'armGroupLabels': ['Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF', 'Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF']}, {'name': 'F/TAF (High Dose TOS)', 'type': 'DRUG', 'description': '60/7.5 mg tablet for oral suspension (TOS) administered orally', 'armGroupLabels': ['Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF']}, {'name': 'F/TAF (Low Dose TOS)', 'type': 'DRUG', 'description': '30/3.75 mg TOS administered orally', 'armGroupLabels': ['Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF']}, {'name': 'F/TAF (Lowest Dose TOS)', 'type': 'DRUG', 'description': '15/1.88 mg TOS administered orally', 'armGroupLabels': ['Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF']}, {'name': 'E/C/F/TAF', 'type': 'DRUG', 'otherNames': ['Genvoya®'], 'description': '150/150/200/10 mg tablet administered orally', 'armGroupLabels': ['Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E/C/F/TAF) or B/F/TAF']}, {'name': 'E/C/F/TAF (Low Dose)', 'type': 'DRUG', 'description': '90/90/120/6 mg tablet administered orally', 'armGroupLabels': ['Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E/C/F/TAF) or B/F/TAF']}, {'name': 'Cobicistat (High Dose)', 'type': 'DRUG', 'otherNames': ['GS-9350', 'Tybost®'], 'description': '150 mg tablet administered orally', 'armGroupLabels': ['Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF']}, {'name': 'Cobicistat (Low Dose)', 'type': 'DRUG', 'otherNames': ['GS-9350'], 'description': '90 mg tablet administered orally', 'armGroupLabels': ['Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF']}, {'name': 'Cobicistat (TOS)', 'type': 'DRUG', 'otherNames': ['GS-9350'], 'description': '30 mg TOS administered orally', 'armGroupLabels': ['Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF']}, {'name': 'B/F/TAF (High Dose)', 'type': 'DRUG', 'otherNames': ['Biktarvy®', 'GS-9883/F/TAF'], 'description': '50/200/25 mg FDC tablet administered orally', 'armGroupLabels': ['Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF', 'Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF)', 'Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E/C/F/TAF) or B/F/TAF', 'Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF']}, {'name': 'B/F/TAF (Low Dose)', 'type': 'DRUG', 'otherNames': ['GS-9883/F/TAF'], 'description': '30/120/15 mg FDC tablet administered orally', 'armGroupLabels': ['Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF', 'Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF)', 'Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E/C/F/TAF) or B/F/TAF', 'Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF']}, {'name': 'B/F/TAF (High Dose TOS)', 'type': 'DRUG', 'otherNames': ['GS-9883/F/TAF'], 'description': '15/60/7.52 mg TOS administered orally', 'armGroupLabels': ['Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF', 'Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF)', 'Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF']}, {'name': 'B/F/TAF (Low Dose TOS)', 'type': 'DRUG', 'otherNames': ['GS-9883/F/TAF'], 'description': '7.5/30/3.76 mg TOS administered orally', 'armGroupLabels': ['Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF', 'Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF)']}, {'name': 'B/F/TAF (Lowest Dose TOS)', 'type': 'DRUG', 'otherNames': ['GS-9883/F/TAF'], 'description': '3.76/15/1.88 mg TOS administered orally', 'armGroupLabels': ['Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF', 'Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B/F/TAF)']}, {'name': '3rd ARV Agent', 'type': 'DRUG', 'description': "A 3rd antiretroviral (ARV) agent administered as defined by the investigator, according to the prescribing information. A 3rd ARV agent may include: boosted atazanavir (ATV), boosted lopinavir (LPV/r), boosted darunavir (DRV), unboosted efavirenz (EFV), unboosted nevirapine (NVP), unboosted raltegravir (RAL), or unboosted dolutegravir (DTG), or any other unspecified agent that is available in a participant's country", 'armGroupLabels': ['Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF', 'Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F/TAF) or B/F/TAF']}, {'name': 'Nucleos(t)ide reverse transcriptase inhibitors (NRTI)', 'type': 'DRUG', 'description': 'NRTIs administered as defined by the investigator, according to the prescribing information. NRTIs may include zidovudine (ZDV), stavudine (d4T), didanosine (ddI), abacavir (ABC), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), lamivudine (3TC), or emtricitabine (FTC)', 'armGroupLabels': ['Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF']}, {'name': 'ATV', 'type': 'DRUG', 'description': 'Administered according to the prescribing information', 'armGroupLabels': ['Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF']}, {'name': 'DRV', 'type': 'DRUG', 'description': 'Administered according to the prescribing information', 'armGroupLabels': ['Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF']}, {'name': 'Lopinavir Boosted with ritonavir (LPV/r)', 'type': 'DRUG', 'description': 'Administered according to the prescribing information', 'armGroupLabels': ['Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B/F/TAF']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1141 ACG', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Helios Salud', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '0816-00383', 'city': 'Panama City', 'status': 'RECRUITING', 'country': 'Panama', 'facility': 'Hospital del Niño', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'zip': '7505', 'city': 'Cape Town', 'status': 'RECRUITING', 'country': 'South Africa', 'facility': 'University of Stellenbosch', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '3629', 'city': 'Durban', 'status': 'RECRUITING', 'country': 'South Africa', 'facility': 'Enhancing Care Foundation', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '2038', 'city': 'Johannesburg', 'status': 'RECRUITING', 'country': 'South Africa', 'facility': 'WITS RHI Research Centre', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '2112', 'city': 'Johannesburg', 'status': 'RECRUITING', 'country': 'South Africa', 'facility': 'Rahima Moosa Mother and Child Hospital', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '7626', 'city': 'Paarl', 'status': 'RECRUITING', 'country': 'South Africa', 'facility': 'Be Part Yoluntu Centre', 'geoPoint': {'lat': -33.73378, 'lon': 18.97523}}, {'zip': '0087', 'city': 'Pretoria', 'status': 'RECRUITING', 'country': 'South Africa', 'facility': 'The Aurun Institute', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '2013', 'city': 'Soweto', 'status': 'RECRUITING', 'country': 'South Africa', 'facility': 'Perinatal HIV Research Unit', 'geoPoint': {'lat': -26.26781, 'lon': 27.85849}}, {'zip': '10700', 'city': 'Bangkok Noi', 'status': 'RECRUITING', 'country': 'Thailand', 'facility': 'Faculty of Medicine - Mahidol University', 'geoPoint': {'lat': 13.76266, 'lon': 100.47798}}, {'zip': '40002', 'city': 'Khon Kaen', 'status': 'RECRUITING', 'country': 'Thailand', 'facility': 'Khon Kaen University', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}, {'zip': '10005', 'city': 'Kampala', 'status': 'RECRUITING', 'country': 'Uganda', 'facility': 'Joint Clinical Research Centre', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'city': 'Kampala', 'status': 'RECRUITING', 'country': 'Uganda', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'city': 'Harare', 'status': 'RECRUITING', 'country': 'Zimbabwe', 'facility': 'University of Zimbabwe Clinical Research Centre', 'geoPoint': {'lat': -17.82772, 'lon': 31.05337}}], 'centralContacts': [{'name': 'Gilead Clinical Study Information Center', 'role': 'CONTACT', 'email': 'GileadClinicalTrials@gilead.com', 'phone': '1-833-445-3230 (GILEAD-0)'}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}