Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-01-18 @ 7:31 PM
Study NCT ID:
NCT01322932
Status:
COMPLETED
Last Update Posted:
2015-12-22
First Post:
2011-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tenofovir, Emtricitabine and Efavirenz Late Switch to a Single Pill: Patients' Opinion Survey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], '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'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-21', 'studyFirstSubmitDate': '2011-03-24', 'studyFirstSubmitQcDate': '2011-03-24', 'lastUpdatePostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient adherence', 'timeFrame': 'V0, V1, V2', 'description': 'by questionnaire in both subgroups and by MEMS data in the adherence subgroup'}, {'measure': 'Adverse events and symptoms', 'timeFrame': 'V0, V1, V2', 'description': 'by questionnaires'}, {'measure': 'Treatment management', 'timeFrame': 'V0, V1, V2', 'description': 'Treatment management according to meals, timing, disruptive daily schedule By questionnaire'}, {'measure': 'Patient satisfaction of the switch', 'timeFrame': 'V1, V2', 'description': 'By questionnaire'}], 'secondaryOutcomes': [{'measure': 'Impact of switch on clinical outcomes', 'timeFrame': 'V0, V1, V2', 'description': 'Clincal outcomes = viral load, CD4 count, resistance, EFV blood level. By medical file'}, {'measure': "Patients' acceptance of switch", 'timeFrame': 'V-1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Medication Adherence', 'HIV Infection', 'efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination [Substance Name]', 'efavirenz', 'emtricitabine', 'Patient Satisfaction', 'tenofovir disoproxil fumarate'], 'conditions': ['HIV Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess adherence, tolerability and satisfaction of each eligible HIV subjects switching from a two- or three-pill tenofovir-emtricitabine-efavirenz (TDF-FTC-EFV) to a one-pill TDF-FTC-EFV treatment.', 'detailedDescription': 'Each eligible patient will be screened from de SHCS database. Each refusal and drop-out will be documented. A pre-visit (V-1) will be scheduled for informed consent, V0 for inclusion (V-1 and V0 may occur on the same day), V1 one month post-inclusion and V2 4 to 7 months post-inclusion. V0, V1 and V2 will be planned during regular medical visits.\n\nEligible patients either get their cART in their usual pharmacy according to standard of care, or take part in a routine adherence-enhancing program(adherence subgroup)run by the pharmacists of the outpatient medical clinic.\n\nIn the adherence subgroup, adherence is assessed electronically by MEMS (Medication event monitoring system) monitors on a regular basis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients under TDF-FTC-EFV followed up at the Service of Infectious Disease of the University Hospital of Lausanne and enrolled in the Swiss HIV Cohort Study (SHCS) Adherence subgroup: patients enrolled in the HIV adherence program at the pharmacy of the Department of Ambulatory Care \\& Community Medicine in Lausanne.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients under TDF-FTC-EFV\n* followed up at the Service of Infectious Disease of the University Hospital of Lausanne\n* enrolled in the SHCS\n\nExclusion Criteria:\n\n* patients receiving TDF-FTC-EFV in combination with other ARTs\n* patients under TDF-FTC-EFV for less than 3 months\n* patients not fluent in French'}, 'identificationModule': {'nctId': 'NCT01322932', 'briefTitle': "Tenofovir, Emtricitabine and Efavirenz Late Switch to a Single Pill: Patients' Opinion Survey", 'organization': {'class': 'OTHER', 'fullName': 'Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland'}, 'officialTitle': "HIV-positive Patients Under Tenofovir, Emtricitabine and Efavirenz Therapy Switching From a Two-pill Regimen to a Single Pill Regimen: Patients'Opinion Survey", 'orgStudyIdInfo': {'id': '151/10'}}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois et Policlinique Medicale Universitaire', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Matthias Cavassini, M.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Centre Hospitalier Universitaire Vaudois'}, {'name': 'Marie-Paule Schneider, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland'}, {'name': 'Olivier Bugnon, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland'}, {'name': 'Aurélie Gertsch, PhD Student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, {'name': 'Swiss HIV Cohort Study', 'class': 'NETWORK'}, {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pharmacist, PhD', 'investigatorFullName': 'Marie Schneider', 'investigatorAffiliation': 'Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland'}}}}