Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT00002202
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparison of 141W94 and Indinavir 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': 'D019469', 'term': 'Indinavir'}, {'id': 'C095108', 'term': 'amprenavir'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 460}}, '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': ['HIV-1', 'Drug Therapy, Combination', 'HIV Protease Inhibitors', 'Indinavir', 'RNA, Viral', 'VX 478', 'Reverse Transcriptase Inhibitors', 'Anti-HIV Agents', 'Viral Load'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if 141W94 is as safe and effective as indinavir when used with nucleoside reverse transcriptase inhibitors (NRTIs) for 48 weeks. This study also examines what effect other drugs have on how the body handles 141W94.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nPatients must have:\n\n* Documented HIV infection.\n* HIV RNA \\>= 400 copies/ml within 14 days prior to randomized study drug administration.\n* No active AIDS-defining opportunistic infection or disease.\n* Signed, informed consent from parent or legal guardian of patients less than 18 years of age.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Unlikely to complete the randomized dosing period.\n* Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with drug absorption or ability to take oral medications.\n* Serious medical conditions (e.g., diabetes, cardiac dysfunction, hepatitis) that would compromise patient safety.\n\nConcurrent Medication:\n\nExcluded:\n\n* Cytotoxic chemotherapeutic agents (except local treatment for Kaposi's sarcoma).\n* Investigational treatments (treatment through Treatment IND or expanded-access programs are evaluated individually).\n* Immunomodulating agents such as systemic, high-dose corticosteroids, interleukins, or interferons.\n* Terfenadine, astemizole, cisapride, triazolam, midazolam, and ergotamine/dihydroergotamine-containing regimens.\n\nConcurrent Treatment:\n\nExcluded:\n\nRadiation therapy (except local treatment for Kaposi's sarcoma).\n\nPatients with the following prior conditions are excluded:\n\nClinically relevant pancreatitis or hepatitis within the last 6 months.\n\nPrior Medication:\n\nExcluded:\n\n* Cytotoxic chemotherapeutic agents within 30 days of study drug administration (except local treatment for Kaposi's sarcoma).\n* Protease inhibitor therapy.\n* Dose of vaccine through an investigational HIV vaccine trial within the 3 months prior to study drug administration.\n* Immunomodulating agents such as systemic, high-dose corticosteroids, interleukins, or interferons within 30 days of study drug administration.\n\nPrior Treatment:\n\nExcluded:\n\nRadiation therapy within 30 days prior to study drug administration (except local treatment for Kaposi's sarcoma).\n\nRisk Behavior:\n\nExcluded:\n\nCurrent alcohol or illicit drug use that may interfere with drug absorption or ability to take oral medication.\n\nRequired:\n\nNRTI therapy at day of entry and up to screening.\n\nRequired:\n\n\\>= 12 weeks of NRTI therapy."}, 'identificationModule': {'nctId': 'NCT00002202', 'briefTitle': 'A Comparison of 141W94 and Indinavir in HIV-Infected Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Phase III Trial to Compare the Safety and Antiviral Efficacy of 141W94 With Indinavir in Combination With Nucleoside Reverse Transcriptase Inhibitor (NRTI) Therapy, in NRTI-Experienced, Protease Inhibitor (PI)-Naive, HIV-1-Infected Patients.', 'orgStudyIdInfo': {'id': '264E'}, 'secondaryIdInfos': [{'id': 'PROA/B3006'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Indinavir sulfate', 'type': 'DRUG'}, {'name': 'Amprenavir', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'East Bay AIDS Ctr', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'AIDS Healthcare Foundation', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Saint Francis Mem Hosp', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'ViRx Inc', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Univ of Colorado Health Sciences Ctr', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Whitman Walker Clinic Inc', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'CRI 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 Dept of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Univ Med School', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane Univ Med School', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '021182393', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Med Ctr / Evans - 556', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Med Ctr', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '681985400', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Univ of Nebraska Med Ctr', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '10001', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Community Research Initiative on AIDS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10027', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Harlem Hosp', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The Nalle Clinic / Clinical Research Dept', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '43614', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Med College of Ohio / Division of Infectious Diseases', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'The Research and Education Group', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Methodist Hosp', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75217', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Community Oriented Primary Care', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '775550835', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ of Texas Med Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '770303498', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine / Dept of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23666', 'city': 'Hampton', 'state': 'Virginia', 'country': 'United States', 'facility': 'Hampton Roads Med Specialists', 'geoPoint': {'lat': 37.02987, 'lon': -76.34522}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glaxo Wellcome', 'class': 'INDUSTRY'}}}}