Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-30 @ 4:12 PM
Study NCT ID:
NCT00002333
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Saquinavir and Zalcitabine, Used Alone and Together, in the Treatment of Advanced HIV Infection in Patients Who Stopped Taking or Who Cannot Take Zidovudine
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': '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': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'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': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 900}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1995-02', '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': ['Zalcitabine', 'Drug Therapy, Combination', 'Acquired Immunodeficiency Syndrome', 'AIDS-Related Complex', 'Saquinavir', 'HIV Protease Inhibitors'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Revicki D, Swartz C. Quality of life outcomes of saquinavir, zalcitabine and combination saquinavir-zalcitabine therapy for advanced HIV-infection. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:113 (abstract no 266)'}]}, 'descriptionModule': {'briefSummary': 'To compare the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone, zalcitabine (dideoxycytidine; ddC) alone, and both in combination, in patients discontinuing or unable to take zidovudine (AZT).', 'detailedDescription': 'Patients are randomized to one of three treatment regimens: ddC alone, Ro 31-8959 alone, and ddC plus Ro 31-8959. Treatment continues for at least 48 weeks. Patients are stratified by baseline CD4 count. (Per 09/26/94 amendment, a fourth arm, lower dose Ro 31-8959 plus ddC, was discontinued.)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* G-CSF and erythropoietin.\n* Prophylaxis or chronic suppression/maintenance therapy with dapsone, aerosolized pentamidine, isoniazid, rifampin, fluoroquinolones, pyrazinamide, ethambutol, fluconazole, itraconazole, acyclovir, clotrimazole, nystatin, trimethoprim/sulfamethoxazole, pyrimethamine, folic acid, sulfadiazine, clindamycin, and fansidar.\n\nConcurrent Treatment:\n\nAllowed:\n\n* Limited localized radiation therapy to the skin.\n\nPatients must have:\n\n* Documented HIV infection.\n* CD4 count 50 - 300 cells/mm3.\n* Received prior AZT that has been discontinued at least 28 days prior to study entry.\n* No active opportunistic infection requiring immediate treatment.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Signs or symptoms of peripheral neuropathy.\n* Malabsorption or inadequate oral intake (defined as unable to eat one or more meals daily because of chronic nausea, emesis, or abdominal/oral-esophageal discomfort.\n* Malignancy, visceral Kaposi's sarcoma, or lymphoma requiring systemic chemotherapy and/or radiotherapy within the next 48 weeks.\n* Any grade 3 or worse laboratory or clinical abnormality.\n* Inability to comply with protocol requirements.\n\nConcurrent Medication:\n\nExcluded:\n\n* Other antiretroviral drugs.\n* Experimental drugs.\n* Nephrotoxic or hepatotoxic drugs.\n* Drugs likely to cause peripheral neuropathy.\n* Antineoplastic agents.\n* Biologic response modifiers.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Radiation therapy other than limited localized therapy to skin.\n\nPatients with the following prior conditions are excluded:\n\n* History of non-Hodgkin's lymphoma.\n* Unexplained fever \\>= 38.5 C (101.5 F) persisting for 14 days or longer within the 28 days prior to study entry.\n* Unexplained, chronic diarrhea (defined as 3 or more loose stools daily) persisting for 14 days or longer within the 28 days prior to study entry.\n* History of grade 2 or worse peripheral neuropathy.\n\nPrior Medication:\n\nExcluded:\n\n* Prior HIV proteinase inhibitor.\n* Prior antiretroviral therapy other than AZT.\n* Acute therapy for opportunistic infection within 14 days prior to study entry.\n\nPrior Treatment:\n\nExcluded:\n\n* More than 3 units of blood in any 21-day period within 3 months prior to study entry.\n\nRequired:\n\n* Prior AZT."}, 'identificationModule': {'nctId': 'NCT00002333', 'briefTitle': 'A Study of Saquinavir and Zalcitabine, Used Alone and Together, in the Treatment of Advanced HIV Infection in Patients Who Stopped Taking or Who Cannot Take Zidovudine', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Randomized, Double-Blind, Multicenter, Parallel Study of Ro 31-8959 (Saquinavir; HIV Proteinase Inhibitor) Alone, HIVID (Dideoxycytidine; Zalcitabine, ddC) Alone, and Both in Combination, as Treatment for Advanced HIV Infection (CD4 50-300 Cells/mm3) in Patients Discontinuing or Unable to Take Retrovir (Zidovudine; AZT) Therapy', 'orgStudyIdInfo': {'id': '229A'}, 'secondaryIdInfos': [{'id': 'NV 14256B'}, {'id': 'NV 14256A'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Saquinavir', 'type': 'DRUG'}, {'name': 'Zalcitabine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90710', 'city': 'Harbor City', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Foundation Hosp', 'geoPoint': {'lat': 33.79002, 'lon': -118.29785}}, {'zip': '920930679', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '900121973', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'CARE Ctr / UCLA Med Ctr', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UCD', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF - San Francisco Gen Hosp', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94114', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Davies Med Ctr / c/o HIV Institute', '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': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco Veterans Administration Med Ctr', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Oaks Med Group / Rsch & Scientific Investigation', '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': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor - UCLA Med Ctr', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '20422', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Veterans Administration Med Ctr', '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': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ of Miami Dept of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Stratogen of South Florida', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'AIDS Research Consortium of Atlanta', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30327', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'West Paces Clinical Research Incoporated', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'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': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Univ of Kansas School of Medicine', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane Univ Med School', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'New England Med Ctr', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts Gen Hosp / Harvard Med School', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'New England Deaconess Hosp', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Harper Hosp', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63108', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington Univ School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'UMDNJ - New Jersey Med School / Cooper Hosp', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '08103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'UMDNJ - New Jersy Med School', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Med College', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Beth Israel Med Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Saint Vincent's Hosp and 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': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State Univ Hosp', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97201', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health Sciences Univ', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson Med College', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19146', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Graduate Hosp / Tuttleman Cancer Ctr', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38163', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Univ of Tennessee', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75219', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Oaklawn Physicians Group', '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': '77005', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Univ of Washington / Harborview Med Ctr', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Southern Alberta HIV Clinic', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster Univ Med Ctr', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Science Ctr', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Clinique Medicale L'Actuele", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Gen Hosp', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'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'}}}}