Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 11:33 PM
Study NCT ID:
NCT00002334
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 Zidovudine (AZT) Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Patients With Little or No Previous Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D000386', 'term': 'AIDS-Related Complex'}], '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'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019258', 'term': 'Saquinavir'}, {'id': 'D015215', 'term': 'Zidovudine'}, {'id': 'D016047', 'term': 'Zalcitabine'}], 'ancestors': [{'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 3000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1996-09', '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', 'Acquired Immunodeficiency Syndrome', 'AIDS-Related Complex', 'Zidovudine', 'Saquinavir', 'HIV Protease Inhibitors'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Collier CA, Coombs RW, Schoenfeld DA, Bassett R, Hooper C, Timphone J, Baruch A, Corey L. A comparative study of saquinavir (SAQ), and zidovudine (ZDV) vs. ZDV and zalcitabine (ddC) vs. SAQ, ZDV, and ddC. Program Abstr Intersci Conf Antimicrob Agents Chemother. 1994 Oct 4-7:60'}]}, 'descriptionModule': {'briefSummary': 'To compare, in zidovudine (AZT)-naive patients, the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone versus AZT alone versus AZT in combination with Ro 31-8959, zalcitabine (ddC), or both. To compare various disease markers among the different regimens.', 'detailedDescription': 'Patients are randomized to receive a minimum of 80 weeks of AZT alone, AZT plus ddC, AZT plus Ro 31-8959, or all three drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Erythropoietin and G-CSF.\n\nConcurrent Treatment:\n\nAllowed:\n\n* Local skin radiotherapy.\n\nPatients must have:\n\n* HIV infection.\n* CD4 count 50 - 350 cells/mm3.\n* No prior antiretroviral therapy OR less than 16 weeks of prior AZT.\n* No acute serious opportunistic infections requiring immediate treatment.\n* No unexplained fever persisting for 14 days within 90 days prior to study entry.\n* No significant unexplained diarrhea persisting for 14 days within 30 days prior to study entry.\n* No visceral Kaposi's sarcoma or lymphoma currently requiring chemotherapy and/or radiotherapy.\n* Life expectancy of at least 80 weeks.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Malabsorption.\n* Severe chronic diarrhea.\n* Inadequate oral intake (unable to eat one or more meals daily because of chronic nausea, emesis, or abdominal/oral-esophageal discomfort).\n* Any grade 3 or worse toxicity.\n* Inability to comply with study requirements.\n\nConcurrent Medication:\n\nExcluded:\n\n* Other investigational agents.\n* Antineoplastic agents.\n* Biologic response modifiers (including interferons).\n* Foscarnet.\n* Anti-HIV drugs other than the study drugs.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Radiotherapy (other than local skin radiotherapy).\n\nPatients with the following prior condition are excluded:\n\nHistory of non-Hodgkin's lymphoma.\n\nPrior Medication:\n\nExcluded:\n\n* Acute therapy for opportunistic infection within 14 days prior to study entry.\n* Prior HIV proteinase inhibitor."}, 'identificationModule': {'nctId': 'NCT00002334', 'briefTitle': 'A Study of Zidovudine (AZT) Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Patients With Little or No Previous Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Randomized, Multicenter, Double-Blind, Phase III, Parallel Study of Zidovudine (AZT) Alone Versus AZT Plus Zalcitabine (Dideoxycytidine; ddC) Versus AZT Plus Saquinavir Mesylate (Ro 31-8959 ; HIV Proteinase Inhibitor) Versus AZT Plus ddC Plus Ro 31-8959 in Previously Untreated or Minimally Pretreated HIV-Infected Patients With CD4 Lymphocyte Counts From 50 to <= 350 Cells/mm3', 'orgStudyIdInfo': {'id': '229B'}, 'secondaryIdInfos': [{'id': 'SV 14604C'}, {'id': 'SV 14604A'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Saquinavir', 'type': 'DRUG'}, {'name': 'Zidovudine', 'type': 'DRUG'}, {'name': 'Zalcitabine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Body Positive', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UCD Med Ctr', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94114', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Davies Med Ctr', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Mount Zion Med Ctr / UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Oaks Med Group', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '94086', 'city': 'Sunnyvale', 'state': 'California', 'country': 'United States', 'facility': 'Sunnyvale Med Clinic', 'geoPoint': {'lat': 37.36883, 'lon': -122.03635}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Novum Inc', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20060', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Howard Univ', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Veterans Administration Med Ctr', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '331361013', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ of Miami School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cook County Hosp', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Rush Presbyterian - Saint Luke's Med Ctr", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '701122699', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane Univ Med School', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts Gen Hosp', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'HIV Wellness Ctr / Univ Med Ctr', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Beth Israel Med Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Harkness Pavilion', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Univ Hosp of Cleveland / Case Western Reserve Univ', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73117', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Univ of Oklahoma Health Science / Pharmacy Practice', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '152063817', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Novum Inc', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '78404', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'facility': 'Respiratory Associates', 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '75219', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'N Texas Ctr for AIDS & Clin Rsch', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '775550882', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ TX Galveston Med Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Thomas Street Clinic / Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '981224379', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Univ of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '009275800', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'San Juan Veterans Administration Med Ctr', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}}}}