Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-02 @ 9:35 AM
Study NCT ID:
NCT02191332
Status:
COMPLETED
Last Update Posted:
2014-07-16
First Post:
2014-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study in Patients With HIV Infection Type 1 After Switching to a Viramune®-Containing Therapy Regimen
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': 'D019829', 'term': 'Nevirapine'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-12'}, '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': '2001-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in viral load (HIV-RNA)', 'timeFrame': 'Baseline, after 26 and 52 weeks'}, {'measure': 'Change in CD4 cell count', 'timeFrame': 'Baseline, after 26 and 52 weeks'}, {'measure': 'Change in lipid status (lipodystrophy, triglycerides, cholesterol)', 'timeFrame': 'Baseline, after 26 and 52 weeks', 'description': 'verbal rating scale'}, {'measure': 'Change in glucose tolerance', 'timeFrame': 'Baseline, after 26 and 52 weeks', 'description': 'verbal rating scale'}], 'secondaryOutcomes': [{'measure': 'Assessment of subjective well-being', 'timeFrame': 'up to 52 weeks', 'description': 'verbal rating scale'}, {'measure': 'Assessment of tolerability by physician and patient', 'timeFrame': 'after 26 and 52 weeks', 'description': 'verbal rating scale'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'up to 52 weeks'}]}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'Observational study to collect data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) despite switching from protease inhibitor to nonnucleoside reverse transcriptase inhibitor (NNRTI) (Viramune®).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV treatment centres and HIV out-patient facilities', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male or female patients with HIV type 1 infection\n\nExclusion Criteria:\n\n* Counter-indications according to summary of product characteristics (SPC) for Viramune tablets\n* No persons under 18\n* Pregnancy and breast-feeding\n* Use of oral contraceptives\n* Use of drugs affecting CYP450 3A metabolism'}, 'identificationModule': {'nctId': 'NCT02191332', 'briefTitle': 'Observational Study in Patients With HIV Infection Type 1 After Switching to a Viramune®-Containing Therapy Regimen', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Collecting Data in Patients With HIV Infection Type 1 After Switching From a Protease Inhibitor-containing Therapy Regimen and a Viral Load Below Detection Level to a Viramune®-Containing Therapy Regimen', 'orgStudyIdInfo': {'id': '1100.1305'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Viramune', 'interventionNames': ['Drug: Viramune']}], 'interventions': [{'name': 'Viramune', 'type': 'DRUG', 'armGroupLabels': ['Viramune']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}