Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:53 PM
Study NCT ID:
NCT00002294
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 Fluconazole in the Treatment of Cryptococcal Meningitis in Patients With AIDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016919', 'term': 'Meningitis, Cryptococcal'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D017088', 'term': 'AIDS-Related Opportunistic Infections'}, {'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D003453', 'term': 'Cryptococcosis'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D016921', 'term': 'Meningitis, Fungal'}, {'id': 'D020314', 'term': 'Central Nervous System Fungal Infections'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'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': 'D009894', 'term': 'Opportunistic Infections'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015725', 'term': 'Fluconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1989-12', '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': ['AIDS-Related Opportunistic Infections', 'Meningitis', 'Cryptococcosis', 'Fluconazole', 'Acquired Immunodeficiency Syndrome'], 'conditions': ['Meningitis, Cryptococcal', 'HIV Infections']}, 'descriptionModule': {'briefSummary': 'To compare the safety and effectiveness of fluconazole with that of placebo as maintenance treatment for preventing the relapse of cryptococcal meningitis in patients with AIDS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Antiviral therapy (e.g., zidovudine).\n* Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP).\n\nConcurrent Treatment:\n\nAllowed:\n\n* Radiation therapy for mucocutaneous Kaposi's sarcoma.\n\nPatients must be oriented to person, place, and time and able to give written informed consent.\n\n* Patients must have had an acute episode of cryptococcal meningitis that was documented by recovery and identification of cryptococcus from lumbar cerebrospinal fluid (CSF) culture within 4 months of study entry.\n* Adequate therapy will consist of 6 - 16 weeks of treatment with amphotericin B alone, amphotericin B + oral flucytosine, or a period of the combination followed by amphotericin alone. Adequate regimens will include:\n* A minimum total amphotericin B dose of 2 grams as monotherapy.\n* 6 weeks of flucytosine at 150 mg/kg/day (or levels of 20 to 100 mcg/ml demonstrated) plus amphotericin B at an average daily dose of at least 0.3 mg/kg/day or to a total dose of 1 gram.\n* After a shorter period of the combination amphotericin/flucytosine therapy, an additional Y grams of amphotericin B monotherapy will make therapy adequate where Y = 2 gm-(X weeks combination therapy / 3 weeks).\n* For example, a patient who received 3 weeks of combination followed by amphotericin alone would need an additional 2 gm - 3 weeks/3 weeks = 1 gm of amphotericin B.\n* Patients need not be receiving amphotericin B at the time of randomization but must begin study maintenance therapy within 3 weeks of cessation of primary amphotericin B therapy.\n\nPrior Medication:\n\nAllowed:\n\n* Antiviral therapy (e.g., zidovudine (AZT)).\n* Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP).\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* Clinical evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.\n* History of allergy or intolerance of imidazoles, azoles, or amphotericin B.\n* Moderate or severe liver disease.\n\nConcurrent Medication:\n\nExcluded:\n\n* Intrathecal amphotericin B.\n* Coumarin-type anticoagulants.\n* Oral hypoglycemics.\n* Barbiturates.\n* Phenytoin.\n* Immunostimulants.\n* Investigational drugs or approved (licensed) drugs for investigational indications.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Lymphocyte replacement.\n\nPatients with the following are excluded:\n\n* Clinical evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.\n* History of allergy or intolerance of imidazoles, azoles, or amphotericin B.\n* Moderate or severe liver disease defined by specific lab values.\n* Inability to take oral medications reliably.\n\nPrior Medication:\n\nExcluded:\n\n* Intrathecal amphotericin B.\n* Coumarin-type anticoagulants.\n* Oral hypoglycemics.\n* Barbiturates.\n* Phenytoin.\n* Immunostimulants.\n* Investigational drugs or approved (licensed) drugs for investigational indications.\n\nPrior Treatment:\n\nExcluded:\n\n* Lymphocyte replacement."}, 'identificationModule': {'nctId': 'NCT00002294', 'briefTitle': 'A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients With AIDS', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'Double Blind Placebo Controlled Study of Fluconazole (UK-49,858) for Maintenance Treatment of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome', 'orgStudyIdInfo': {'id': '012A'}, 'secondaryIdInfos': [{'id': '056-114A'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Fluconazole', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Dr Robert Larsen', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92668', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'UCI Med Ctr', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Dr Paul Rothman', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Univ School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}}}}