Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-02-21 @ 1:34 AM
Study NCT ID:
NCT00643968
Status:
COMPLETED
Last Update Posted:
2008-06-30
First Post:
2008-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tenofovir DF + Efavirenz (TDF+EFV) Versus Tenofovir DF + Efavirenz + Lamivudine (TDF+EFV+3TC) Maintenance Regimen in Virologically Controlled Patients: COOL Trial
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-27', 'studyFirstSubmitDate': '2008-03-20', 'studyFirstSubmitQcDate': '2008-03-25', 'lastUpdatePostDateStruct': {'date': '2008-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the efficacy of TDF+3TC+EFV versus TDF+EFV QD to maintain plasma HIV-1 RNA BLQ (< 50 copies/mL) (c/mL) at 48 weeks (W48)', 'timeFrame': '48 wks'}], 'secondaryOutcomes': [{'measure': 'Comparison of the two arms for genotypic resistance profile in case of virological failure', 'timeFrame': '48 wks'}, {'measure': 'CD4 changes from baseline', 'timeFrame': '48 wks'}, {'measure': 'Evolution of the lipid profile and morphological changes in fat distribution, and safety', 'timeFrame': '48 wks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV virological control', 'Lipid profile and morphological fat distribution', 'Treatment Experienced'], 'conditions': ['HIV Infections']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.gileadclinicaltrials.com/pdf/GS-02-1016_synopsis.pdf', 'label': 'Study Results'}]}, 'descriptionModule': {'briefSummary': 'Primary objective: Evaluation of the efficacy of TDF+3TC+EFV versus TDF+EFV QD to maintain plasma HIV-1 RNA BLQ (\\< 50 copies/mL) (c/mL) at 48 weeks (W48)\n\nMain Secondary objectives:\n\nComparison of the two arms for genotypic resistance profile in case of virological failure\n\nCD4 changes from baseline\n\nEvolution of the lipid profile and morphological changes in fat distribution, and safety\n\nEfficacy and genotypic profile data, results of lipid markers, morphological changes and main biological parameters'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable HAART ≥ 3 months\n* HIV-1 RNA \\< 50 c/mL ≥ 6 months\n* No HAART failure history\n\nExclusion Criteria:\n\n* Weight \\> 45 kg\n* No CD4+ cell count criteria\n* No significant laboratory or clinical abnormalities\n* Creatinine Clearance \\> 60 mL/min'}, 'identificationModule': {'nctId': 'NCT00643968', 'acronym': 'COOL', 'briefTitle': 'Tenofovir DF + Efavirenz (TDF+EFV) Versus Tenofovir DF + Efavirenz + Lamivudine (TDF+EFV+3TC) Maintenance Regimen in Virologically Controlled Patients: COOL Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'Randomized Multicenter Open-Label, Pilot Trial to Evaluate the Efficacy and Safety of Switching HIV-1 Stable Infected Patients Under HAART to a New Once Daily Triple Therapy Combination Including EFV+3TC+TDF Versus a Dual QD Therapy Containing EFV+TDF', 'orgStudyIdInfo': {'id': 'GS-FR-104-1016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'TDF+EFV', 'interventionNames': ['Drug: EFV+TDF']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'TDF+3TC+EFV', 'interventionNames': ['Drug: EFV+3TC+TDF']}], 'interventions': [{'name': 'EFV+TDF', 'type': 'DRUG', 'armGroupLabels': ['1']}, {'name': 'EFV+3TC+TDF', 'type': 'DRUG', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'France and French West Indies', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Aldo Trylesinski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gilead Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr Aldo Trylesinski- Gilead Sciences', 'oldOrganization': 'Gilead Sciences, Inc.'}}}}