Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-07 @ 10:18 PM
Study NCT ID:
NCT02191202
Status:
COMPLETED
Last Update Posted:
2014-07-16
First Post:
2014-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Switching to NNRTI-based Therapy on the Quality of Life of HIV-infected Patients With Virological Suppression
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 283}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-15', 'studyFirstSubmitDate': '2014-07-15', 'studyFirstSubmitQcDate': '2014-07-15', 'lastUpdatePostDateStruct': {'date': '2014-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in World Health Organization Quality of Life - HIV (WHOQOL-HIV) score', 'timeFrame': 'Baseline, month 1, 6 and 12'}], 'secondaryOutcomes': [{'measure': 'Comparison of Short version of the Medical Outcomes Study Short-Form General Health Survey-36 (SF12) scores of the study population compared to the general population', 'timeFrame': 'Baseline, 12 months'}, {'measure': 'Changes in symptom scale score', 'timeFrame': 'Baseline, month 1, 6 and 12'}, {'measure': 'Changes in Hospital Anxiety and Depression scale (HADS)', 'timeFrame': 'Baseline, month 1, 6 and 12'}, {'measure': 'Changes in cluster of differentiation 4 (CD4) cell count', 'timeFrame': 'Baseline and month 3, 6, 9, 12'}, {'measure': 'Changes in viral load', 'timeFrame': 'Baseline and month 3, 6, 9, 12'}, {'measure': 'Changes in liver function tests', 'timeFrame': 'Baseline and month 3, 6, 9, 12'}, {'measure': 'Changes in total cholesterol', 'timeFrame': 'Baseline, month 6 and 12'}, {'measure': 'Changes in triglycerides', 'timeFrame': 'Baseline, month 6 and 12'}, {'measure': 'Changes in fasting blood glucose', 'timeFrame': 'Baseline, month 6 and 12'}, {'measure': 'Changes in haemoglobin', 'timeFrame': 'Baseline, month 6 and 12'}, {'measure': 'Changes from baseline in plasma urea', 'timeFrame': 'Baseline, month 12'}, {'measure': 'Changes from baseline in creatinine', 'timeFrame': 'Baseline, month 12'}]}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'Observational study to evaluate therapeutic switch to a NNRTI-based regimen on quality of life of HIV-positive patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospital physicians, specialized in treatment of patients infected by the HIV', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NNRTI-naive patients with positive HIV serology, treated with at least triple combination therapy, with a viral load \\< 500 copies/ml, in whom a new treatment comprising an NNRTI is initiated for a reason other than inefficacy of treatment will be included\n* Patients must read and write French\n\nExclusion Criteria:\n\n* Patients in whom a new treatment is initiated because of treatment failure\n* new treatment does not comprise an NNRTI'}, 'identificationModule': {'nctId': 'NCT02191202', 'briefTitle': 'Impact of Switching to NNRTI-based Therapy on the Quality of Life of HIV-infected Patients With Virological Suppression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Observational Study of the Impact on Quality-of-life of a Switch From a Virologically Effective Regimen to a Regimen Containing a Non-Nucleoside Reverse Transcriptase Inhibitor (QUALVI) Nevirapine (Viramune®) Clinical Phase IV', 'orgStudyIdInfo': {'id': '1100.1461'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)', 'interventionNames': ['Drug: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)']}], 'interventions': [{'name': 'Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)', 'type': 'DRUG', 'armGroupLabels': ['Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}