Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2026-01-01 @ 6:40 AM
Study NCT ID:
NCT00038506
Status:
COMPLETED
Last Update Posted:
2015-04-08
First Post:
2002-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Of Investigational Regimen Combining FDA Approved HIV Drugs In HIV Subjects Experiencing Early Virologic Failure
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': 'C418262', 'term': 'abacavir, lamivudine, and zidovudine drug combination'}, {'id': 'D000068698', 'term': 'Tenofovir'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2002-05-31', 'studyFirstSubmitQcDate': '2002-05-31', 'lastUpdatePostDateStruct': {'date': '2015-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HIV viral load response at 48 weeks as measured by proportion of subjects with undetectable viral load.', 'timeFrame': '48 weeks'}], 'secondaryOutcomes': [{'measure': 'Safety Viral load response at 24 weeks Change in T-cell count Resistance Health outcomes', 'timeFrame': '24 weeks'}]}, 'conditionsModule': {'keywords': ['HIV-1 TRIZIVIR Tenofovir'], 'conditions': ['HIV Infection']}, 'descriptionModule': {'briefSummary': 'This study is a 48-week study to evaluate the efficacy and safety of an investigational regimen combining FDA approved HIV drugs in antiretroviral-experienced subjects failing on their first highly active antiretroviral therapy regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently on an initial HAART (highly active antiretroviral therapy) regimen of 3TC/ZDV or 3TC/d4T and a PI (protease inhibitor) -boosted or unboosted- or NNRTI (non-nucleoside reverse transcriptase inhibitor).\n* Plasma HIV - 1 RNA was \\<400 copies/ml on at least 2 documented occasions prior to viral rebound.\n* Have a plasma HIV - 1 RNA value \\>400 copies/ml and \\<10,000 copies/ml on 2 documented successive occasions (including screen) separated by at least 2 weeks.\n* A CD4+ lymphocyte count less than or equal to 100.\n\nExclusion Criteria:\n\n* Have not taken Abacavir (ZIAGEN or TRIZIVIR) or tenofovir (VIREAD) previously.\n* Have not had an AIDS defining illness within 30 days of screen.\n* Pregnant or breast-feeding.\n* Specified viral genotypes upon screening.\n* And other inclusion or exclusion criteria to be evaluated by the physician.'}, 'identificationModule': {'nctId': 'NCT00038506', 'briefTitle': 'Study Of Investigational Regimen Combining FDA Approved HIV Drugs In HIV Subjects Experiencing Early Virologic Failure', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'A Phase IV, Open-label, Multicenter Study of Treatment With TRIZIVIR (Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg) Twice Daily and Tenofovir 300mg Once-daily for 48 Weeks in HIV-infected Subjects Experiencing Early Virologic Failure (ZIAGEN Intensification Protocol)', 'orgStudyIdInfo': {'id': 'ESS 30005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'abacavir/lamivudine/zidovudine', 'type': 'DRUG'}, {'name': 'tenofovir', 'type': 'DRUG', 'otherNames': ['abacavir/lamivudine/zidovudine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'GSK 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