Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT00002151
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 Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'C070715', 'term': 'celgosivir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1996-03', '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', 'AIDS-Related Complex', 'Zidovudine', 'MDL 28574'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'To characterize the safety and efficacy of fixed doses of MDL 28,574A administered alone and in combination with zidovudine ( AZT ) in patients with asymptomatic or mildly symptomatic HIV infection. To examine the demographic effects on population pharmacokinetics and pharmacodynamics of MDL 28,574A alone and in combination with AZT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Prior antiretroviral agents for up to 6 months per agent.\n\nPatients must have:\n\n* HIV infection.\n* Asymptomatic or mildly symptomatic.\n* CD4 count 301 - 500 cells/mm3.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following condition are excluded:\n\nUnable or unwilling to comply with study procedures.\n\nConcurrent Medication:\n\nExcluded:\n\n* Chemoprophylactic therapy for mycobacterial infection.\n* Any nonstudy prescription medications without approval of investigator.\n\nPatients with the following prior conditions are excluded:\n\n* History of grade 3 or 4 toxicity to \\<= 600 mg/day AZT.\n* History of intolerance to lactose.\n* Chronic diarrhea within 6 months prior to study entry.\n* Unexplained intermittent or chronic fever, defined as temperature \\>= 38.5 C for any 7 days within the 30 days prior to study entry.\n\nPrior Medication:\n\nExcluded:\n\n* Antiretroviral therapy within 2 weeks prior to study entry.\n* Prior HIV vaccines.\n* Biological response modifiers within 30 days prior to study entry.\n* Prior foscarnet.\n* Any investigational drug with a washout \\< 5 half-lives prior to study entry.\n* Any medications known to alter renal, hepatic, or hematologic / immunologic function (such as barbiturates, phenothiazines, cimetidine, immunomodulators, etc.) within 14 days prior to study entry.\n\nRecent history of alcohol and/or drug abuse.'}, 'identificationModule': {'nctId': 'NCT00002151', 'briefTitle': 'A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients', 'orgStudyIdInfo': {'id': '221C'}, 'secondaryIdInfos': [{'id': '028574PR0004'}, {'id': 'NDPR0004'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Celgosivir hydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '366880002', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Clinical Investigations Health Services', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'California Clinical Trials Med Group', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Southwest Community Based AIDS Treatment Group - COMBAT', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF - San Francisco Gen Hosp', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington Univ / Hershey Med Ctr', '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': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Independent Investigator', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'North Broward Hosp District', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Ctr', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '32960', 'city': 'Vero Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Independent Investigator', 'geoPoint': {'lat': 27.63864, 'lon': -80.39727}}, {'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Ctr for Special Immunology', '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': 'New Orleans Institute of Clinical Investigation', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Univ Health Ctr', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '64132', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Antibiotic Research Associates', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '071032842', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'North Jersey Community Research Initiative', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Community Health Network', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '117948153', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY / Health Sciences Ctr at Stony Brook', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '43608', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Infectious Disease Associates', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Portland Veterans Adm Med Ctr / Rsch & Education Grp', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '18840', 'city': 'Sayre', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Guthrie Clinic', 'geoPoint': {'lat': 41.97896, 'lon': -76.5155}}, {'zip': '752359103', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ of Texas Southwestern Med Ctr of Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '775550835', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ TX Galveston Med Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77006', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Clinical Research Network', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoechst Marion Roussel', 'class': 'INDUSTRY'}}}}