Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 11:41 PM
Study NCT ID:
NCT01516060
Status:
COMPLETED
Last Update Posted:
2013-09-19
First Post:
2012-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Neurocognitive Sub-study of Encore1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C098320', 'term': 'efavirenz'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-18', 'studyFirstSubmitDate': '2012-01-19', 'studyFirstSubmitQcDate': '2012-01-19', 'lastUpdatePostDateStruct': {'date': '2013-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint is the comparison between of neurocognitive function in patients initiating sdEFV and 400EFV', 'timeFrame': '48 weeks'}], 'secondaryOutcomes': [{'measure': 'The association between week 4 plasma EFV levels and change from baseline neurocognitive function to week 4 and 24.', 'timeFrame': 'Week 24'}, {'measure': 'To assess dynamic changes in neurocognitive function over the total duration of follow-up.', 'timeFrame': '96 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'The purpose is to investigate whether HIV and HIV medication can affect certain areas of brain function. This study will look at possible changes in brain function including memory, concentration and thought processes to see if there are any differences between the two doses of efavirenz used in the Encore1 study and also the level of efavirenz in the blood'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All subjects entering into the main study protocol at participating centres will be eligible to enter this sub-study.\n\nExclusion Criteria:\n\n* Existing neurological brain disease\n* Recent (\\<6months ) head injury\n* Current major depression or psychosis\n* Current alcohol abuse\n* Intended use of recreational drugs during study period\n* Uncontrolled medical conditions deemed to potentially interfere with cognitive function (e.g. uncontrolled diabetes, pyrexial illness, uraemia etc)'}, 'identificationModule': {'nctId': 'NCT01516060', 'briefTitle': 'The Neurocognitive Sub-study of Encore1', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kirby Institute'}, 'officialTitle': 'The Neurocognitive Sub Study of Encore1:A Randomised, Double-Blind, Placebo-Controlled, Clinical Trial to Compare the Safety and Efficacy of Reduced Dose Efavirenz (EFV) With Standard Dose EFV Plus 2N(t)RTI in Antiretroviral-naïve HIV-Infected Individuals Over 96 Weeks A Randomised, Double-blind, Placebo-controlled, Clinical Trial to Compare the Safety and Efficacy of Reduced Dose Efavirenz (EFV) With Standard Dose EFV Plus Two Nucleotide Reverse Transcriptase Inhibitors (N(t)RTI) in Antiretroviral-naïve HIV-infected Individuals Over 96 Weeks', 'orgStudyIdInfo': {'id': 'Encore1-NC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reduced dose Efavirenz arm', 'description': "Patient's on main study that was randomised to receive TDF (300mg qd)/FTC (200mg qd) + EFV (400mg qd; 2 x 200mg + 1 x 200mg placebo qd).", 'interventionNames': ['Drug: Efavirenz']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normal Efavirenz dose arm', 'description': "Patient's on main study randomised to receive tenofovir (TDF) (300mg qd)/emtricitabine (FTC) (200mg qd) + EFV (600mg qd; 3 x 200mg qd)", 'interventionNames': ['Drug: Efavirenz']}], 'interventions': [{'name': 'Efavirenz', 'type': 'DRUG', 'description': '400mg qd; 2 x 200mg', 'armGroupLabels': ['Reduced dose Efavirenz arm']}, {'name': 'Efavirenz', 'type': 'DRUG', 'description': '600mg qd; 3 x 200mg qd', 'armGroupLabels': ['Normal Efavirenz dose arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bangkok', 'country': 'Thailand', 'facility': 'HIVNAT Research Collaboration', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Rebekah Puls', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kirby Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kirby Institute', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'The HIV Netherlands Australia Thailand Research Collaboration', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}