Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-26 @ 4:15 PM
Study NCT ID:
NCT00002195
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients
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': 'C095108', 'term': 'amprenavir'}, {'id': 'D019259', 'term': 'Lamivudine'}, {'id': 'D015215', 'term': 'Zidovudine'}], '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'}, {'id': 'D013936', 'term': 'Thymidine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 290}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1998-11', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Drug Therapy, Combination', 'Zidovudine', 'HIV Protease Inhibitors', 'Lamivudine', 'VX 478', 'Reverse Transcriptase Inhibitors', 'Anti-HIV Agents', 'Viral Load'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if it is safe and effective to add 141W94 to an anti-HIV regimen that includes retrovir plus epivir.', 'detailedDescription': 'This is a double-blind, placebo-controlled, two-arm study comparing treatment with a triple regimen consisting of 141W94, retrovir, and epivir and a double regimen consisting of retrovir and epivir.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nPatients must have:\n\n* HIV-positive status.\n* Screening viral load \\>= 10,000 copies/mm3 14 days prior to entry.\n* CD4+ cell counts \\>= 200 cells/mm3 14 days prior to entry.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\nClinical diagnosis of AIDS (CDC 1993 Classification C).\n\nConcurrent Medication:\n\nExcluded:\n\nTerfenadine, astemizole, cisapride, triazolam, medazolam, and ergotamine/dihydroergotamine-containing regimens.\n\nPatients with the following prior conditions are excluded:\n\nClinically relevant hepatitis in the previous 6 months.\n\nPrior Medication:\n\nExcluded:\n\n* Greater than 4 weeks of any nucleoside antiretroviral therapy.\n* Previous therapy with an HIV protease inhibitor.\n* Cytotoxic chemotherapeutic agents within 4 weeks prior to entry.\n* Immunomodulating agents within 3 months prior to entry.\n\nPrior Treatment:\n\nExcluded:\n\nRadiotherapy within 4 weeks prior to entry.\n\nRisk Behavior:\n\nExcluded:\n\nCurrent alcohol or illicit drug use that may interfere with the patient's ability to comply with the dosing schedule or protocol evaluations."}, 'identificationModule': {'nctId': 'NCT00002195', 'briefTitle': 'A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Phase III Trial to Evaluate the Safety and Antiviral Efficacy of 141W94 in Combination With Retrovir and Epivir Compared to Retrovir and Epivir Alone in Patients With HIV Infection.', 'orgStudyIdInfo': {'id': '264D'}, 'secondaryIdInfos': [{'id': 'PROA3001'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Amprenavir', 'type': 'DRUG'}, {'name': 'Lamivudine', 'type': 'DRUG'}, {'name': 'Zidovudine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Oaks Research', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Dr Bruce Rashbaum', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Community Research Initiative of South Florida', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Community Research Initiative of Central Florida', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ of Miami School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60610', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Chicago Ctr for Clinical Research', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02445', 'city': 'Brookline', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Community Research Initiative of New England', 'geoPoint': {'lat': 42.33176, 'lon': -71.12116}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Saint Vincent's AIDS Ctr", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Methodist Hosp', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glaxo Wellcome', 'class': 'INDUSTRY'}}}}