Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-02-22 @ 7:24 AM
Study NCT ID:
NCT02342769
Status:
COMPLETED
Last Update Posted:
2019-02-11
First Post:
2015-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Non-Interventional Observational Study of Use of TRIUMEQ and Corresponding Monitoring Measures in Clinical Practice in Germany
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C562325', 'term': 'dolutegravir'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 403}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-07', 'studyFirstSubmitDate': '2015-01-15', 'studyFirstSubmitQcDate': '2015-01-15', 'lastUpdatePostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of therapeutic monitoring measures in HIV-infected patients', 'timeFrame': 'up to 3 years', 'description': 'Descriptive documentation of the frequency of therapeutic monitoring measures in HIV-infected patients under TRIUMEQ in routine daily practice in Germany'}], 'secondaryOutcomes': [{'measure': 'Type of the therapeutic monitoring measures', 'timeFrame': 'up to 3 years', 'description': 'Descriptive characterization of therapeutic monitoring measures in HIV-infected patients under TRIUMEQ in routine daily practice in Germany'}, {'measure': 'Details on conduct and logistics of HLA-B*5701 testing', 'timeFrame': 'Baseline', 'description': 'Descriptive characterization of conduct and logistics of HLA-B\\*5701 testing in HIV-infected patients under TRIUMEQ in routine daily practice in Germany'}, {'measure': 'Number of participants with Serious Adverse Events and drug-related adverse events as a measure of safety and tolerability', 'timeFrame': 'up to 3 years', 'description': 'To evaluate the frequency and type of serious adverse events and drug-related adverse events in patients treated with dolutegravir'}, {'measure': 'Efficacy', 'timeFrame': 'up to 3 years', 'description': 'Defined as viral load \\< 50 copies/ml'}, {'measure': 'Resistance profile', 'timeFrame': 'up to 3 years', 'description': 'To characterise resistance profile in case of virological failure'}, {'measure': 'Patient satisfaction', 'timeFrame': 'up to 3 years', 'description': 'To evaluate the change in patient satisfaction relative to baseline in patients treated with TRIUMEQ'}, {'measure': 'Reasons for selecting TRIUMEQ', 'timeFrame': 'Baseline'}, {'measure': 'Reasons for discontinuing TRIUMEQ', 'timeFrame': 'up to 3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'TRIUMPH is a prospective, non-interventional observational study on the use of the fixdose combination TRIUMEQ (Dolutegravir/Abacavir/Lamivudine) and the respective monitoring measures in the practice of HIV care in Germany. The primary study objective is a descriptive report of the incidence of therapeutic monitoring measures in HIV-infected patients under TRIUMEQ therapy in everyday routine practice in Germany. The study is designed to enroll approximately 400 patients. There are no protocol-mandated visits or procedures associated with the study. Each patient is expected to participate for a maximum of 3 years or until premature discontinuation (i.e., discontinuation of TRIUMEQ, due to death, withdrawal of consent, lost to follow-up. TRIUMEQ is a registered trademark of the ViiV Healthcare group of companies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Approx. 40 HIV treatment sites in Germany are planned to be involved in the documentation. The recruitment target is to include a total of 400 patients in the study across Germany. In order to allow for adequately answering in particular the problems regarding HLA-B\\*5701 testing, at least half of the recruited population should not have received abacavir (ABC) in their prior therapy. Each site will be allowed to recruit a maximum of 5 patients per month and a maximum of 20 patients in total. If the monthly quota of 5 patients is not utilized, the difference may be transferred to the subsequent months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented HIV infection\n* Age ≥ 18 years\n* HLA-B\\*5701-negative\n* Decision for first initiation of TRIUMEQ therapy made by the attending physician independent of the inclusion in this observational study\n\nExclusion Criteria:\n\n* Prior dolutegravir therapy (cf. also Capping ABC in section 3.3 Recruitment)\n* Participation in a clinical trial during this study'}, 'identificationModule': {'nctId': 'NCT02342769', 'acronym': 'TRIUMPH', 'briefTitle': 'Prospective Non-Interventional Observational Study of Use of TRIUMEQ and Corresponding Monitoring Measures in Clinical Practice in Germany', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'Prospective Non-Interventional Observational Study of Use of Triumeq® and Corresponding Monitoring Measures in Clinical Practice in Germany', 'orgStudyIdInfo': {'id': '202033'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dolutegravir/Abacavir/Lamivudin', 'description': 'Prospective, non-interventional observational study on the use of TRIUMEQ and the respective monitoring measures in the practice of HIV care in Germany. No drug will be provided. No study visits or procedures are mandated per protocol.', 'interventionNames': ['Drug: Dolutegravir/Abacavir/Lamivudin']}], 'interventions': [{'name': 'Dolutegravir/Abacavir/Lamivudin', 'type': 'DRUG', 'description': 'Prospective, non-interventional observational study on the use of TRIUMEQ and the respective monitoring measures in the practice of HIV care in Germany. No drug will be provided. 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