Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-03 @ 2:40 AM
Study NCT ID:
NCT00556634
Status:
COMPLETED
Last Update Posted:
2009-01-15
First Post:
2007-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence and Severity of Neuropsychiatric Adverse Events of Efavirenz Given as a Stepped Dosage vs. the Usual Dosage
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': 'C098320', 'term': 'efavirenz'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-14', 'studyFirstSubmitDate': '2007-11-08', 'studyFirstSubmitQcDate': '2007-11-09', 'lastUpdatePostDateStruct': {'date': '2009-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence and severity of neuropsychiatric side effects', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Virological efficacy', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'efavirenz', 'central nervous system', 'adverse effects'], 'conditions': ['HIV-1 Infection', 'HIV Infection']}, 'referencesModule': {'references': [{'pmid': '19581631', 'type': 'DERIVED', 'citation': 'Gutierrez-Valencia A, Viciana P, Palacios R, Ruiz-Valderas R, Lozano F, Terron A, Rivero A, Lopez-Cortes LF; Sociedad Andaluza de Enfermedades Infecciosas. Stepped-dose versus full-dose efavirenz for HIV infection and neuropsychiatric adverse events: a randomized trial. Ann Intern Med. 2009 Aug 4;151(3):149-56. doi: 10.7326/0003-4819-151-3-200908040-00127. Epub 2009 Jul 6.'}]}, 'descriptionModule': {'briefSummary': 'Background: Neuropsychiatric side effects (NPSEs) occur in a significant proportion of subjects after initiation of efavirenz (EFV) and may limit its use in certain patients.\n\nObjectives: To evaluate the incidence and severity of NPSEs and antiviral efficacy of EFV given as a stepped dosage over 2 weeks versus the usual dosage.\n\nMethods: Randomized, double blind, multicentric clinical trial in which a progressive dosage (arm A: 200 mg qd for 6 days, 400 mg qd for 7 days and 600 mg qd from day 14 forward) was compared with conventional administration (arm B: 600 mg qd from the first day). All patients received additional treatment with 2 NRTIs.\n\nThe incidence and intensity of NPSEs and sleep disorders were assessed using a Likert-type scale specifically designed. Efficacy was assessed by percent of virological failures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age older than 18 years\n* HIV-1 infection\n* Women of child-bearing age: negative pregnancy test\n* Ability to understand and sign a written consent form\n\nExclusion Criteria:\n\n* Pregnancy..\n* Illegal drug or methadone use.\n* Major psychiatric disease antecedents or starting new psychotropic agents in the last 4 weeks\n* Concomitant treatment with rifamycins, protease inhibitors or drugs which interfere the pharmacokinetic of efavirenz.\n* Hepatic insufficiency'}, 'identificationModule': {'nctId': 'NCT00556634', 'briefTitle': 'Incidence and Severity of Neuropsychiatric Adverse Events of Efavirenz Given as a Stepped Dosage vs. the Usual Dosage', 'organization': {'class': 'NETWORK', 'fullName': 'Sociedad Andaluza de Enfermedades Infecciosas'}, 'officialTitle': 'Randomized, Double-Blinded Clinical Trial to Evaluate the Incidence and Severity of Neuropsychiatric Side Effects and Antiviral Efficacy of Efavirenz Given as a Stepped Dosage Over 2 Weeks Versus the Usual Dosage in HIV-Infected Patients.', 'orgStudyIdInfo': {'id': 'SAEI_EFV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: Efavirenz']}, {'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: Efavirenz']}], 'interventions': [{'name': 'Efavirenz', 'type': 'DRUG', 'description': 'Efavirenz given in a stepped dosage over 2 weeks (200 mg qd for 6 days plus placebo, 400 mg qd for 7 days plus placebo and 600 mg qd from day 14 forward)\n\nOR\n\nEfavirenz usual dosage (600 mg/day from the first day)', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Almería', 'state': 'Almeria', 'country': 'Spain', 'facility': 'Hospital Torrecardenas', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}, {'city': 'Cadiz', 'state': 'Cadiz', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta del Mar', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'city': 'Jerez de la Frontera', 'state': 'Cadiz', 'country': 'Spain', 'facility': 'Hospital de Jerez', 'geoPoint': {'lat': 36.68645, 'lon': -6.13606}}, {'city': 'Córdoba', 'state': 'Cordoba', 'country': 'Spain', 'facility': 'Hospital Universitario Reina Sofía', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'city': 'Huelva', 'state': 'Huelva', 'country': 'Spain', 'facility': 'Hospital Juan Ramon Jimenez', 'geoPoint': {'lat': 37.26638, 'lon': -6.94004}}, {'city': 'Málaga', 'state': 'Malaga', 'country': 'Spain', 'facility': 'Hospital Universitario Carlos Haya', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Málaga', 'state': 'Malaga', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '41013', 'city': 'Seville', 'state': 'Seville', 'country': 'Spain', 'facility': 'Hospitales Universitarios Virgen del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Seville', 'state': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario de Valme', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Seville', 'state': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'overallOfficials': [{'name': 'Luis F Lopez-Cortes, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospitales Universitarios Virgen del Rocio. Seville. Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sociedad Andaluza de Enfermedades Infecciosas', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Junta de Andalucia', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Luis Fernando Lopez-Cortes', 'oldOrganization': 'Servicio Andaluz de Salud. Hospitales Uiversitarios Virgen del Rocíoi'}}}}