Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-25 @ 7:59 PM
Study NCT ID:
NCT00380159
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2006-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-Label, 48-Week Extension Study of Elvucitabine in Combination With Background Antiretroviral Therapy (ART) for Participants Who Have Completed Study ACH443-014A
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D012897', 'term': 'Slow 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': 'C099405', 'term': 'dexelvucitabine'}, {'id': 'D019259', 'term': 'Lamivudine'}, {'id': 'D000068679', 'term': 'Emtricitabine'}], 'ancestors': [{'id': 'D016047', 'term': 'Zalcitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'dispFirstSubmitDate': '2014-01-20', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-07', 'studyFirstSubmitDate': '2006-09-21', 'dispFirstSubmitQcDate': '2014-01-20', 'studyFirstSubmitQcDate': '2006-09-21', 'dispFirstPostDateStruct': {'date': '2014-02-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Assess The Safety Of 48 Weeks Of 10 mg/daily (QD) Of Elvucitabine In Combination With ART', 'timeFrame': 'September 2008'}], 'secondaryOutcomes': [{'measure': 'To Describe The Anti-viral Activity Of Elvucitabine In Combination With ART As Measured By Plasma HIV-1 Ribonucleic Acid (RNA) Over 24 Weeks', 'timeFrame': 'September 2008'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Extension study to Study ACH443-014A'], 'conditions': ['Human Immunodeficiency Virus (HIV)-1 Infection']}, 'descriptionModule': {'briefSummary': 'To assess the safety of 48 weeks of treatment with 10 milligrams (mg) of elvucitabine in combination with background antiretroviral therapy (ART) in participants who completed Study ACH443-014A and meet the inclusion and exclusion criteria.', 'detailedDescription': 'This study is an open-label extension study for participants who have completed 14 days of treatment in Study ACH443-014A and meet all inclusion and exclusion criteria. Elvucitabine treatment (10 mg) will begin on Day 1 (Day 15 following completion of Study ACH443-014A) for all consenting participants in combination with background ART as determined by the Principal Investigator. Participants will have clinical and laboratory assessments every 2 weeks for the first 8 weeks and then every 4 weeks to Week 48.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants who have completed 14 days of treatment in Study ACH443-014A and who, in the Investigator's judgment, remain candidates to receive elvucitabine together with background ART.\n\nExclusion Criteria:\n\n* Failure to meet inclusion criteria"}, 'identificationModule': {'nctId': 'NCT00380159', 'briefTitle': 'Open-Label, 48-Week Extension Study of Elvucitabine in Combination With Background Antiretroviral Therapy (ART) for Participants Who Have Completed Study ACH443-014A', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alexion Pharmaceuticals, Inc.'}, 'officialTitle': 'An Open-Label, 48-Week Extension Study of Elvucitabine Administered In Combination With Background Antiretroviral Agents in Participants Who Have Completed 14 Days of Treatment in Protocol ACH443-014A.', 'orgStudyIdInfo': {'id': 'ACH443-018'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Elvucitabine', 'type': 'DRUG', 'description': 'Elvucitabine 10 mg in combination with background ART'}, {'name': 'Lamivudine', 'type': 'DRUG'}, {'name': 'Emtricitabine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bonn', 'country': 'Germany', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Cologne', 'country': 'Germany', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexion Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Achillion, a wholly owned subsidiary of Alexion', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}