Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 12:28 AM
Study NCT ID:
NCT03518060
Status:
COMPLETED
Last Update Posted:
2024-10-16
First Post:
2018-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dolutegravir/Rilpivirine, Antiretroviral Efficacy Study Using Real-world Data in Subjects With Human Immunodeficiency Virus (HIV)-1
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'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': 'D014777', 'term': 'Virus Diseases'}, {'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': 'C000629908', 'term': 'dolutegravir, rilpivirine drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.', 'eventGroups': [{'id': 'EG000', 'title': 'Participants Who Received JULUCA', 'description': 'Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \\[DTG\\] / Rilpivirine \\[RPV\\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.', 'otherNumAtRisk': 200, 'deathsNumAtRisk': 200, 'otherNumAffected': 41, 'seriousNumAtRisk': 200, 'deathsNumAffected': 1, 'seriousNumAffected': 52}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'CD4 lymphocytes decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Nervous system disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}], 'seriousEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Myopericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Drug ineffective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Acute hepatitis B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Angiogram', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Continuous glucose monitoring', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Nitrite urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Gallbladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Hypopharyngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Malignant peritoneal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Cerebellar stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Acute stress disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Drug abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Abdominal cavity drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Cardioversion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Chemotherapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Mitral valve repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Shoulder operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Sustained Virologic Suppression at Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Who Received JULUCA', 'description': 'Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \\[DTG\\] / Rilpivirine \\[RPV\\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.'}], 'classes': [{'title': 'HIV-RNA <50 c/mL', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}]}]}, {'title': 'HIV-RNA 50-200 c/mL and subsequent measurement <50 c/mL', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'HIV-RNA 50-200 copies/mL & subsequent measurement >=50 c/mL', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'HIV-RNA 50-200 c/mL & missing subsequent measurement', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation due to intolerability & LOCF HIV-RNA <50 c/mL', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation due to death & LOCF HIV-RNA <50 c/mL', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation due to other reasons & LOCF HIV-RNA <50 c/mL', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation due to other reasons & LOCF HIV-RNA >=50 c/mL', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Lost to follow-up & LOCF HIV-RNA <50 c/mL', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'On drug, but no HIV-RNA in window & LOCF HIV-RNA <50 c/mL', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Year 3', 'description': 'Virologic suppression (VS) was defined as HIV-RNA less than (\\<) 50 copies (c)/mL for at least 6 months or, if between 50-200 c/mL with a subsequent next available measurement (within 120 days) \\<50 c/mL at Year 3 follow-up. Any subsequent measurement was accepted as a consecutive measurement as long as measured no later than 120 days after the initial measurement. If no subsequent HIV-RNA measurement was performed within 120 days, this was scored as a confirmed HIV-RNA greater than or equal to (\\>=)200 c/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified Full Analysis Set (mFAS) which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Who Received JULUCA', 'description': 'Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \\[DTG\\] / Rilpivirine \\[RPV\\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.'}], 'classes': [{'title': 'HIV-RNA <50 c/mL - at Year 1', 'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000'}]}]}, {'title': 'HIV-RNA 50-200 c/mL and subsequent measurement <50 c/mL - at Year 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'HIV-RNA 50-200 c/mL & subsequent measurement >=50 copies/mL - at Year 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'HIV-RNA 50-200 c/mL & missing subsequent measurement - at Year 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'HIV-RNA >=200 copies/mL - at Year 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation due to intolerability & LOCF HIV-RNA <50 c/mL - at Year 1', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation due to death & LOCF HIV-RNA <50 c/mL - at Year 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation due to other reasons & LOCF HIV-RNA <50 c/mL - at Year 1', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation due to other reasons & LOCF HIV-RNA >=50 c/mL - at Year 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Lost to follow-up & LOCF HIV-RNA <50 c/mL - at Year 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'On drug, but no HIV-RNA in window & LOCF HIV-RNA <50 c/mL - at Year 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'HIV-RNA <50 c/mL - at Year 2', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}]}]}, {'title': 'HIV-RNA 50-200 c/mL and subsequent measurement <50 c/mL - at Year 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'HIV-RNA 50-200 c/mL & subsequent measurement >=50 copies/mL - at Year 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'HIV-RNA 50-200 c/mL & missing subsequent measurement - at Year 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'HIV-RNA >=200 c/mL - at Year 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation due to intolerability & LOCF HIV-RNA <50 c/mL - at Year 2', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation due to death & LOCF HIV-RNA <50 c/mL - at Year 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation due to other reasons & LOCF HIV-RNA <50 c/mL - at Year 2', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation due to other reasons & LOCF HIV-RNA >=50 c/mL - at Year 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Lost to follow-up & LOCF HIV-RNA <50 c/mL - at Year 2', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'On drug, but no HIV-RNA in window & LOCF HIV-RNA <50 c/mL - at Year 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Year 1 and Year 2', 'description': 'VS was defined as HIV-RNA \\<50 c/mL for at least 6 months or, if between 50-200 c/mL with a subsequent next available measurement (within 120 days) \\<50 c/mL. Any subsequent measurement was accepted as a consecutive measurement as long as measured no later than 120 days after the initial measurement. If no subsequent HIV-RNA measurement was performed within 120 days, this was scored as a confirmed HIV-RNA \\>=200 c/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Low Level Viremia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Who Received JULUCA', 'description': 'Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \\[DTG\\] / Rilpivirine \\[RPV\\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.'}], 'classes': [{'title': 'HIV-RNA 50-200 c/mL and subsequent measurement >=50 c/mL - at Year 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'mHIV-RNA 50-200 c/mL and subsequent measurement >=50 c/mL - at Year 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'HIV-RNA 50-200 c/mL and subsequent measurement >=50 c/mL - at Year 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Year 1, Year 2 and Year 3', 'description': 'Low level viremia was defined as a VL greater than (\\>) 50 to \\<200 c/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Virologic Rebound', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Who Received JULUCA', 'description': 'Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \\[DTG\\] / Rilpivirine \\[RPV\\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.'}], 'classes': [{'title': 'HIV-RNA >=200 c/mL - at Year 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'HIV-RNA >=200 c/mL - at Year 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'HIV-RNA >=200 c/mL - at Year 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Year 1, Year 2 and Year 3', 'description': 'Virologic rebound was defined as two consecutive VL measurements of \\>=200 c/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Switch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Who Received JULUCA', 'description': 'Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \\[DTG\\] / Rilpivirine \\[RPV\\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.'}], 'classes': [{'title': 'Discontinuation due to intolerability and LOCF HIV-RNA <50 c/mL - at Year 1', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation due to intolerability and LOCF HIV-RNA <50 c/mL - at Year 2', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation due to intolerability and LOCF HIV-RNA <50 c/mL - at Year 3', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Year 1, Year 2 and Year 3', 'description': 'The treatment switch could have been due to virologic failure (VF) or due to intolerability and last observation carried forward (LOCF) as determined at the discretion of the physician.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Number of Monitoring Measures During the 3-year Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Who Received JULUCA', 'description': 'Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \\[DTG\\] / Rilpivirine \\[RPV\\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '4.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Year 3', 'description': 'The HIV monitoring measures included were defined as HIV-RNA measurements, normalized to participant years.', 'unitOfMeasure': 'Measurements per year', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Who Received JULUCA', 'description': 'Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \\[DTG\\] / Rilpivirine \\[RPV\\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Year 3', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal investigational product, whether or not related to the medicinal investigational product.\n\nA SAEs was defined as any adverse event meeting the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a congenital anomaly in the off-spring of a participant, was medically significant or could have required intervention to prevent the previously stated outcomes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the safety analysis set (SAS) which included all participants who received at least one dose of DTG+RPV.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reactions (ADRs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Who Received JULUCA', 'description': 'Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \\[DTG\\] / Rilpivirine \\[RPV\\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Year 3', 'description': 'An ADR was defined as a noxious and unintended response to a medicinal investigational product related to any dose where at least a reasonable possibility (i.e. the relationship) cannot be ruled out.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the SAS which included all participants who received at least one dose of DTG+RPV.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adherence to Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Who Received JULUCA', 'description': 'Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \\[DTG\\] / Rilpivirine \\[RPV\\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.'}], 'classes': [{'title': 'Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}]}]}, {'title': 'Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}]}]}, {'title': 'Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Year 1, Year 2 and Year 3', 'description': 'Adherence to therapy refers to the missed monthly doses. At each follow-up visit, participants were asked to give an estimation of their level of adherence to their antiretroviral therapy (ART).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations. This analysis was performed only on the participants from the mFAS who completed the self-assessment questionnaire of adherence.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (BL) in Lipid Laboratory Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Who Received JULUCA', 'description': 'Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \\[DTG\\] / Rilpivirine \\[RPV\\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.'}], 'classes': [{'title': 'Change in total cholesterol from BL - at Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-23', 'upperLimit': '19'}]}]}, {'title': 'Change in LDL cholesterol from BL - at Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '-13.5', 'upperLimit': '18'}]}]}, {'title': 'Change in HDL cholesterol from BL - at Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-5.8', 'upperLimit': '3.1'}]}]}, {'title': 'Change in triglycerides from BL - at Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'groupId': 'OG000', 'lowerLimit': '-56', 'upperLimit': '34'}]}]}, {'title': 'Change in total cholesterol from BL - at Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3', 'groupId': 'OG000', 'lowerLimit': '-24', 'upperLimit': '19'}]}]}, {'title': 'Change in LDL cholesterol from BL - at Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '-17', 'upperLimit': '21'}]}]}, {'title': 'Change in HDL cholesterol from BL - at Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'groupId': 'OG000', 'lowerLimit': '-6', 'upperLimit': '4'}]}]}, {'title': 'Change in triglycerides from BL - at Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '-38.5', 'upperLimit': '49.3'}]}]}, {'title': 'Change in total cholesterol from BL - at Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5', 'groupId': 'OG000', 'lowerLimit': '-27', 'upperLimit': '18'}]}]}, {'title': 'Change in LDL cholesterol from BL - at Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'groupId': 'OG000', 'lowerLimit': '-21', 'upperLimit': '20'}]}]}, {'title': 'Change in HDL cholesterol from BL - at Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-5.8', 'upperLimit': '3.9'}]}]}, {'title': 'Change in triglycerides from BL - at Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-46.5', 'upperLimit': '47'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Year 1, Year 2 and Year 3', 'description': 'To assess the impact on the lipid metabolism, changes in the following parameters were analyzed: total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations. This analysis was performed only on the participants from the mFAS who had laboratory parameters data at baseline and at years 1, 2 or 3.'}, {'type': 'SECONDARY', 'title': 'Change in Treatment Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Who Received JULUCA', 'description': 'Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \\[DTG\\] / Rilpivirine \\[RPV\\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.'}], 'classes': [{'title': 'Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5.5'}]}]}, {'title': 'Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}]}]}, {'title': 'Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Year 1, Year 2 and Year 3', 'description': 'The change in HIV treatment satisfaction was assessed with the help of the HIV Treatment Satisfaction questionnaire (HIVTSQs), which is a 10-item-self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility, etc. HIV TSQs total score: unweighted sum of 10 items of the HIV TSQs (range: 0-60; with higher scores indicating greater treatment satisfaction).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations. This analysis was performed only on the participants from the mFAS who completed the HIV TSQs.'}, {'type': 'SECONDARY', 'title': 'Change in Symptom Distress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Who Received JULUCA', 'description': 'Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \\[DTG\\] / Rilpivirine \\[RPV\\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.'}], 'classes': [{'title': 'Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-6', 'upperLimit': '4'}]}]}, {'title': 'Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-8', 'upperLimit': '2'}]}]}, {'title': 'Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-6', 'upperLimit': '3.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Year 1, Year 2 and Year 3', 'description': 'The change in HIV symptom distress was assessed with the help of the HIV Symptom Distress Module (SDM); which is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. SDM total score: unweighted sum of the 20 items (using a 5-point scale, ranging from 0-4), ranging from 0 to 80. Higher scores indicate higher degrees of symptom distress.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations. This analysis was performed only on the participants from the mFAS who completed the HIV SDM.'}, {'type': 'SECONDARY', 'title': 'Number of Participants by Reasons for Therapy Switch to JULUCA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Who Received JULUCA', 'description': 'Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \\[DTG\\] / Rilpivirine \\[RPV\\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.'}], 'classes': [{'title': 'Side effects of previous ART', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}, {'title': 'Potential/real interactions', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Reduction in number of drugs', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'Non-nucleoside reverse transcriptase inhibitor (NRTI) - free regime', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Pill size', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Simplification to a single-tablet regimen', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': "Patient's preference", 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Baseline (Day 1)', 'description': 'The primary and secondary reasons for therapy switch were presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants Who Received JULUCA', 'description': 'Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \\[DTG\\] / Rilpivirine \\[RPV\\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Poor adherence', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal of informed consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Interaction with comedication or comorbidities', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Adverse drug reactions', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}]}], 'preAssignmentDetails': 'A total of 209 participants were enrolled in the full analysis set (FAS) from which 9 participants were excluded due to not meeting the eligibility criteria. Therefore, 200 participants formed the modified FAS (mFAS).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants Who Received JULUCA', 'description': 'Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \\[DTG\\] / Rilpivirine \\[RPV\\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '49.0', 'groupId': 'BG000', 'lowerLimit': '40.0', 'upperLimit': '57.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '< 50 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}]}]}, {'title': '>= 50 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '181', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-30', 'size': 2895098, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-13T09:50', 'hasProtocol': True}, {'date': '2023-08-18', 'size': 1317730, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-05-13T09:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 209}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-11', 'studyFirstSubmitDate': '2018-04-26', 'resultsFirstSubmitDate': '2024-05-13', 'studyFirstSubmitQcDate': '2018-04-26', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-11', 'studyFirstPostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Sustained Virologic Suppression at Year 3', 'timeFrame': 'At Year 3', 'description': 'Virologic suppression (VS) was defined as HIV-RNA less than (\\<) 50 copies (c)/mL for at least 6 months or, if between 50-200 c/mL with a subsequent next available measurement (within 120 days) \\<50 c/mL at Year 3 follow-up. Any subsequent measurement was accepted as a consecutive measurement as long as measured no later than 120 days after the initial measurement. If no subsequent HIV-RNA measurement was performed within 120 days, this was scored as a confirmed HIV-RNA greater than or equal to (\\>=)200 c/mL.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2', 'timeFrame': 'At Year 1 and Year 2', 'description': 'VS was defined as HIV-RNA \\<50 c/mL for at least 6 months or, if between 50-200 c/mL with a subsequent next available measurement (within 120 days) \\<50 c/mL. Any subsequent measurement was accepted as a consecutive measurement as long as measured no later than 120 days after the initial measurement. If no subsequent HIV-RNA measurement was performed within 120 days, this was scored as a confirmed HIV-RNA \\>=200 c/mL.'}, {'measure': 'Number of Participants With Low Level Viremia', 'timeFrame': 'At Year 1, Year 2 and Year 3', 'description': 'Low level viremia was defined as a VL greater than (\\>) 50 to \\<200 c/mL.'}, {'measure': 'Number of Participants With Virologic Rebound', 'timeFrame': 'At Year 1, Year 2 and Year 3', 'description': 'Virologic rebound was defined as two consecutive VL measurements of \\>=200 c/mL.'}, {'measure': 'Number of Participants With Treatment Switch', 'timeFrame': 'At Year 1, Year 2 and Year 3', 'description': 'The treatment switch could have been due to virologic failure (VF) or due to intolerability and last observation carried forward (LOCF) as determined at the discretion of the physician.'}, {'measure': 'Number of Monitoring Measures During the 3-year Follow-up', 'timeFrame': 'Up to Year 3', 'description': 'The HIV monitoring measures included were defined as HIV-RNA measurements, normalized to participant years.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'Up to Year 3', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal investigational product, whether or not related to the medicinal investigational product.\n\nA SAEs was defined as any adverse event meeting the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a congenital anomaly in the off-spring of a participant, was medically significant or could have required intervention to prevent the previously stated outcomes.'}, {'measure': 'Number of Participants With Adverse Drug Reactions (ADRs)', 'timeFrame': 'Up to Year 3', 'description': 'An ADR was defined as a noxious and unintended response to a medicinal investigational product related to any dose where at least a reasonable possibility (i.e. the relationship) cannot be ruled out.'}, {'measure': 'Number of Participants With Adherence to Therapy', 'timeFrame': 'At Year 1, Year 2 and Year 3', 'description': 'Adherence to therapy refers to the missed monthly doses. At each follow-up visit, participants were asked to give an estimation of their level of adherence to their antiretroviral therapy (ART).'}, {'measure': 'Change From Baseline (BL) in Lipid Laboratory Values', 'timeFrame': 'At Year 1, Year 2 and Year 3', 'description': 'To assess the impact on the lipid metabolism, changes in the following parameters were analyzed: total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides.'}, {'measure': 'Change in Treatment Satisfaction', 'timeFrame': 'At Year 1, Year 2 and Year 3', 'description': 'The change in HIV treatment satisfaction was assessed with the help of the HIV Treatment Satisfaction questionnaire (HIVTSQs), which is a 10-item-self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility, etc. HIV TSQs total score: unweighted sum of 10 items of the HIV TSQs (range: 0-60; with higher scores indicating greater treatment satisfaction).'}, {'measure': 'Change in Symptom Distress', 'timeFrame': 'At Year 1, Year 2 and Year 3', 'description': 'The change in HIV symptom distress was assessed with the help of the HIV Symptom Distress Module (SDM); which is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. SDM total score: unweighted sum of the 20 items (using a 5-point scale, ranging from 0-4), ranging from 0 to 80. Higher scores indicate higher degrees of symptom distress.'}, {'measure': 'Number of Participants by Reasons for Therapy Switch to JULUCA', 'timeFrame': 'At Baseline (Day 1)', 'description': 'The primary and secondary reasons for therapy switch were presented.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['2 drug regimen', 'Juluca', 'Rilpivirine', 'Dolutegravir', 'Antiretroviral', 'One pill regimen'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'This was a prospective, non-interventional, single-arm, multi-center study aimed at gathering real-world data on JULUCA use in routine clinical care in Germany, to supplement clinical trial data to further improve/optimize care in HIV positive participants in Germany. Approximately 250 virologically suppressed HIV positive participants on stable antiretroviral therapy (ART) were included in the study at the discretion of treating physician. Eligible participants were followed up for approximately 3 years and data was collected during routine clinical care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Two hundred treatment experienced and virologically suppressed HIV positive participants were included in this study. The participants were included at the discretion of the treating physician based on the local summary of product characteristics (SmPC) of JULUCA.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Greated than or equal to (\\>=)18 years of age.\n* Documented HIV-1 infection.\n* Virologically suppressed (HIV-1 ribonucleic acid \\[RNA\\] less than \\[\\<\\] 50 copies \\[c\\]/mL for at least 6 months)\n* Prescription for JULUCA was issued independently from entering this study.\n* Ability to understand informed consent form and other relevant study documents\n\nExclusion Criteria:\n\n* Any contraindication according to JULUCA SmPC.\n* Documented viral load greater than (\\>) 50 c/mL at any time point within 6 months prior to inclusion into this study.\n* History of treatment failure.\n* Known or suspected substitutions associated with resistance to any non-nucleoside reverse-transcriptase inhibitors (NNRTI) or integrase strand transfer inhibitor (INSTI).\n* Any ART for the treatment of HIV-1 in addition to JULUCA.\n* Hepatitis B virus (HBV)-co-infection.\n* Current participation in the ongoing non-interventional study TRIUMPH (study number: 202033) or any interventional clinical trial irrespective of indication.\n* Previous participation in clinical trials involving JULUCA.'}, 'identificationModule': {'nctId': 'NCT03518060', 'acronym': 'JUNGLE', 'briefTitle': 'Dolutegravir/Rilpivirine, Antiretroviral Efficacy Study Using Real-world Data in Subjects With Human Immunodeficiency Virus (HIV)-1', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'Durability of Antiretroviral Suppression and the Real World Clinical Profile of the Novel 2-Drug Regimen Juluca, a Onepill-Regimen Consisting of Dolutegravir and Rilpivirine, in Routine Clinical Care in Germany', 'orgStudyIdInfo': {'id': '208982'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants who received JULUCA', 'description': 'Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \\[DTG\\] / Rilpivirine \\[RPV\\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.', 'interventionNames': ['Drug: JULUCA']}], 'interventions': [{'name': 'JULUCA', 'type': 'DRUG', 'description': 'JULUCA is a combination of dolutegravir (INSTI) and rilpivirine (NNRTI).', 'armGroupLabels': ['Participants who received JULUCA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52062', 'city': 'Aachen', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10243', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10629', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12163', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14057', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14059', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44787', 'city': 'Bochum', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '09111', 'city': 'Chemnitz', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'zip': '50668', 'city': 'Cologne', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '50674', 'city': 'Cologne', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '45122', 'city': 'Essen', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '20146', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '80331', 'city': 'München', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '80335', 'city': 'München', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '80336', 'city': 'München', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '80801', 'city': 'München', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '81675', 'city': 'München', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '48143', 'city': 'Münster', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '49090', 'city': 'Osnabrück', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.27264, 'lon': 8.0498}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '99427', 'city': 'Weimar', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.9803, 'lon': 11.32903}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ViiV Healthcare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ViiV Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'MUC Research GmbH', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}