Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-29 @ 9:46 PM
Study NCT ID:
NCT00944957
Status:
UNKNOWN
Last Update Posted:
2010-01-12
First Post:
2009-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Preference, Sleep Quality, and Anxiety/Depression: A Comparison of Raltegravir and Efavirenz
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-09-12', 'releaseDate': '2011-08-09'}, {'resetDate': '2011-10-24', 'releaseDate': '2011-09-15'}, {'resetDate': '2011-11-28', 'releaseDate': '2011-10-25'}], 'estimatedResultsFirstSubmitDate': '2011-08-09'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068898', 'term': 'Raltegravir Potassium'}, {'id': 'C098320', 'term': 'efavirenz'}], 'ancestors': [{'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2010-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-01-11', 'studyFirstSubmitDate': '2009-07-21', 'studyFirstSubmitQcDate': '2009-07-22', 'lastUpdatePostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptoms and neurological side effects of study drugs', 'timeFrame': 'baseline, week 2 and week 4'}], 'secondaryOutcomes': [{'measure': 'Levels of daytime sleepiness', 'timeFrame': 'baseline, week 2 and week 4'}, {'measure': 'Sleep Quality', 'timeFrame': 'baseline, week 2 and week 4'}, {'measure': 'Patient preference', 'timeFrame': '4 weeks'}, {'measure': 'Symptoms of depression, anxiety and stress will be assessed', 'timeFrame': 'baseline, week 2 and week 4'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Raltegravir', 'efavirenz', 'anxiety', 'depression', 'sleep quality', 'HIV', 'NNRTI', 'Tritherapy', 'compliance', 'stocrin', 'treatment experienced'], 'conditions': ['Sleep Disorders', 'HIV Infections']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.shcs.ch', 'label': 'Swiss HIV Cohort Study'}, {'url': 'http://www.doctorswiss.ch/bernard-hirschel/', 'label': 'Homepage Bernard Hirschel'}]}, 'descriptionModule': {'briefSummary': 'Efavirenz causes neuropsychiatric side effects and sleep disturbance, including vivid dreams, dizziness, and abnormal tiredness. These symptoms are frequent during the first weeks of treatment, with subsequent attenuation but may not completely resolve even years after efavirenz initiation.\n\nThe investigators plan a four week, randomized, placebo-controlled, double-blind study. In group 1, efavirenz will be replaced with efavirenz placebo plus raltegravir, in group 2, efavirenz would be continued, and raltegravir placebo given in addition. After two weeks, patients in group 1 would switch to the regimen of group 2, and vice versa.\n\nThe primary endpoint of the trial will be patient preference. Sleep quality, daytime sleepiness, and anxiety will also be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients \\> 18 years\n* Signing the study consent form and agree to change ART regimen\n* Stable HAART including EFV since at least 3 months\n* HIV-RNA below 50 copies for at least 3 months\n\nExclusion Criteria:\n\n* No major psychiatric disease (psychosis, severe depression) diagnosed before the initiation of EFV\n* Mentally incompetent patients\n* Pregnancy or lactation Women of childbearing potential must use one or two reliable contraceptive methods during the trial, from day 1 to the end of week 12. Acceptable methods include the birth control pill, IUD, condoms with spermicides. Non-acceptable methods include (non-exhaustive list): Withdrawal, calendar (Onigo method), or spermicides alone.\n* Concomitant renal or hepatic disease:\n\n * Creatinine above 150 micromol/L\n * Transaminases above 5 times upper normal limit\n * Prothrombin (Quick) value below 50%'}, 'identificationModule': {'nctId': 'NCT00944957', 'acronym': 'Switch-ER', 'briefTitle': 'Patient Preference, Sleep Quality, and Anxiety/Depression: A Comparison of Raltegravir and Efavirenz', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Patient Preference, Sleep Quality, and Anxiety/Depression: Comparison of Raltegravir and Efavirenz', 'orgStudyIdInfo': {'id': 'IEC 09-087'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Raltegravir first', 'description': 'Patients treated with Raltegravir for first 2 weeks', 'interventionNames': ['Drug: Raltegravir for the first 2 weeks', 'Drug: Efavirenz for the last 2 weeks']}, {'type': 'EXPERIMENTAL', 'label': 'Efavirenz first', 'description': 'Patients treated with Efavirenz for first 2 weeks', 'interventionNames': ['Drug: Efavirenz for the first 2 weeks', 'Drug: Raltegravir for the last 2 weeks']}], 'interventions': [{'name': 'Raltegravir for the first 2 weeks', 'type': 'DRUG', 'description': 'Patient receives raltegravir and efavirenz placebo during the first 2 weeks', 'armGroupLabels': ['Raltegravir first']}, {'name': 'Efavirenz for the last 2 weeks', 'type': 'DRUG', 'description': 'Patient receives efavirenz and raltegravir placebo during the last 2 weeks', 'armGroupLabels': ['Raltegravir first']}, {'name': 'Efavirenz for the first 2 weeks', 'type': 'DRUG', 'description': 'Efavirenz and raltegravir placebo for the first 2 weeks', 'armGroupLabels': ['Efavirenz first']}, {'name': 'Raltegravir for the last 2 weeks', 'type': 'DRUG', 'description': 'Raltegravir and efavirenz placebo for the last 2 weeks', 'armGroupLabels': ['Efavirenz first']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1211', 'city': 'Geneva', 'state': 'Canton of Geneva', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Bernard BH Hirschel, Professor', 'role': 'CONTACT', 'email': 'bernard.hirschel@hcuge.ch', 'phone': '022 372 98 11', 'phoneExt': '+41'}], 'facility': 'University Hopistal of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'centralContacts': [{'name': 'Bernard BH Hirschel, Professor', 'role': 'CONTACT', 'email': 'bernard.hirschel@hcuge.ch', 'phone': '022 372 98 11', 'phoneExt': '+41'}], 'overallOfficials': [{'name': 'Bernard BH Hirschel, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Geneva Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bern', 'class': 'OTHER'}, {'name': 'University of Lausanne Hospitals', 'class': 'OTHER'}, {'name': 'Hospital Lugano', 'class': 'UNKNOWN'}, {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, {'name': 'Hospital of Neuchâtel', 'class': 'UNKNOWN'}, {'name': 'University Hospital, Zürich', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Professeur Bernard Hirschel', 'oldOrganization': 'Geneva infectious diseases'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-08-09', 'type': 'RELEASE'}, {'date': '2011-09-12', 'type': 'RESET'}, {'date': '2011-09-15', 'type': 'RELEASE'}, {'date': '2011-10-24', 'type': 'RESET'}, {'date': '2011-10-25', 'type': 'RELEASE'}, {'date': '2011-11-28', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Alain Nguyen, Dr, Doctor, University Hospital, Geneva'}}}}