Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-04-18 @ 3:43 PM
Study NCT ID:
NCT02191293
Status:
COMPLETED
Last Update Posted:
2014-07-16
First Post:
2014-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Study in Patients Under Anti-retroviral Combination Therapy Switching to Viramune®
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': 228}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05'}, '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': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in viral load (HIV-RNA)', 'timeFrame': 'Baseline, up to 36 months'}, {'measure': 'Changes in CD4 cell count', 'timeFrame': 'Baseline, up to 36 months'}], 'secondaryOutcomes': [{'measure': 'Changes in body weight', 'timeFrame': 'Baseline, up to 36 months'}, {'measure': 'Changes in general well-being assessed on a 4-point scale', 'timeFrame': 'Baseline, up to 36 months'}, {'measure': 'Changes in lipid parameters', 'timeFrame': 'Baseline, up to 36 months', 'description': 'mg/dl'}, {'measure': 'Changes in glucose', 'timeFrame': 'Baseline, up to 36 months', 'description': 'mg/dl'}, {'measure': 'Changes in liver enzymes', 'timeFrame': 'Baseline, up to 36 months', 'description': 'U/l'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'up to 36 months'}]}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and liver enzymes.'}, '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 and female out-patients with HIV type 1 infection who have achieved a viral load below detection limit (50 copies/ml) for more than 6 months under a previous combination therapy with protease-inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRTI)\n* Women can only be included, if a test has excluded pregnancy\n* Only women can be included, who use a reliable means of contraception during the observational study\n\nExclusion Criteria:\n\n* Known sensitivity to Viramune or one of its excipients\n* Clinically relevant changes in lab findings (e.g. increase in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) by more than five-fold of upper limit normal)\n* Patient is not able to abstain from treatment with ketoconazole, oral contraceptives, and other medication CYP3A metabolism\n* For females:\n\n * Pregnancy\n * Breast-feeding\n * Insufficient or unreliable contraception'}, 'identificationModule': {'nctId': 'NCT02191293', 'briefTitle': 'Long-term Study in Patients Under Anti-retroviral Combination Therapy Switching to Viramune®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Long-term Observational Study in Patients Under Anti-retroviral Combination Therapy Who Were Switched From Protease Inhibitors or Other NNRTI to Viramune® Plus Two Nucleoside Reverse Transcriptase Inhibitors (NRTI) for Reasons of Therapy. (Long-Term Switch)', 'orgStudyIdInfo': {'id': '1100.1402'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Viramune®', 'interventionNames': ['Drug: Viramune® tablets']}], 'interventions': [{'name': 'Viramune® tablets', 'type': 'DRUG', 'armGroupLabels': ['Viramune®']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}