Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT00002120
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Phase I Study of Trimetrexate Glucuronate (TMTX) With Leucovorin (LCV) Protection Plus Dapsone Versus Trimethoprim / Sulfamethoxazole (TMP/SMX) for Treatment of Moderately Severe Episodes of Pneumocystis Carinii Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011020', 'term': 'Pneumonia, Pneumocystis'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D008172', 'term': 'Lung Diseases, Fungal'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D016720', 'term': 'Pneumocystis Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract 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': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C056321', 'term': 'trimetrexate glucuronate'}, {'id': 'D014295', 'term': 'Trimethoprim'}, {'id': 'D013420', 'term': 'Sulfamethoxazole'}, {'id': 'D003622', 'term': 'Dapsone'}, {'id': 'D002955', 'term': 'Leucovorin'}], 'ancestors': [{'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 20}}, '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': ['Trimethoprim-Sulfamethoxazole Combination', 'Trimetrexate', 'Pneumonia, Pneumocystis carinii', 'Leucovorin', 'Dapsone', 'Drug Therapy, Combination', 'Acquired Immunodeficiency Syndrome'], 'conditions': ['Pneumonia, Pneumocystis Carinii', 'HIV Infections']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety of the combination of trimetrexate glucuronate (TMTX) and dapsone with leucovorin protection versus trimethoprim/sulfamethoxazole (TMP/SMX) in patients with AIDS and moderately severe Pneumocystis carinii pneumonia (PCP). To determine the pharmacokinetic parameters of TMTX, leucovorin, and dapsone and of TMP/SMX when given to patients with AIDS and moderately severe PCP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Empiric therapy for other opportunistic pulmonary infection (TB or fungi) for the first 72 hours of study enrollment ONLY, until presence of suspected pathogens can be confidently excluded.\n\nPatients must have:\n\n* AIDS.\n* Confirmed diagnosis of PCP.\n* Alveolar-arterial differences in dissolved oxygen \\>= 35 mm Hg but \\< 55 mm Hg on room air.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Severe renal or hepatic dysfunction.\n* Serious or life-threatening intolerance to TMP/SMX, TMTX, or dapsone.\n* Concurrent pneumothorax.\n* Active pulmonary tuberculosis or other inadequately treated opportunistic pulmonary infection (e.g., Cryptococcus neoforms, CMV). NOTE:\n* Identification of Mycobacterium avium or CMV in sputum or BAL fluid does not exclude, since these organisms may be present without causing disease.\n* Pulmonary Kaposi's sarcoma.\n* Active opportunistic infections or malignancies requiring induction therapy with bone marrow suppressive drugs (e.g., ganciclovir) or hepatotoxic drugs (e.g., chemotherapy).\n* Unable to have arterial blood gases on room air obtained at baseline.\n* Unwilling to undergo bronchoscopy, if sputum induction does not reveal Pneumocystis carinii.\n* Suspected malabsorption (e.g., ileus or severe diarrhea with \\> 6 stools/day).\n* Known absence of G6PD activity.\n* Large volume (1.0 to 1.5 liters) of intravenous fluid (5 percent in water) per 24 hours is medically inadvisable.\n* Unwilling to comply with study design.\n\nConcurrent Medication:\n\nExcluded:\n\n* Induction therapy with bone marrow suppressive drugs (e.g., ganciclovir) or hepatotoxic drugs (e.g., chemotherapy).\n* AZT, ddI, ddC, d4T, or other antiretroviral therapy.\n\nPatients with the following prior condition are excluded:\n\nPrior history of serious or life-threatening intolerance to TMP/SMX. (NOTE:\n\n* Patients with less severe reactions may be included at the discretion of the investigator and primary care provider.)\n\nPrior Medication:\n\nExcluded:\n\n* More than 24 hours of systemic anti-PCP therapy within 2 weeks prior to study entry."}, 'identificationModule': {'nctId': 'NCT00002120', 'briefTitle': 'Randomized Phase I Study of Trimetrexate Glucuronate (TMTX) With Leucovorin (LCV) Protection Plus Dapsone Versus Trimethoprim / Sulfamethoxazole (TMP/SMX) for Treatment of Moderately Severe Episodes of Pneumocystis Carinii Pneumonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'Randomized Phase I Study of Trimetrexate Glucuronate (TMTX) With Leucovorin (LCV) Protection Plus Dapsone Versus Trimethoprim / Sulfamethoxazole (TMP/SMX) for Treatment of Moderately Severe Episodes of Pneumocystis Carinii Pneumonia', 'orgStudyIdInfo': {'id': '224A'}, 'secondaryIdInfos': [{'id': 'TMTX A009'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Trimetrexate glucuronate', 'type': 'DRUG'}, {'name': 'Trimethoprim', 'type': 'DRUG'}, {'name': 'Sulfamethoxazole', 'type': 'DRUG'}, {'name': 'Dapsone', 'type': 'DRUG'}, {'name': 'Leucovorin calcium', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles County / Health Research Assoc / Drew Med Ctr', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'U.S. Bioscience', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Jacobus Pharmaceutical', 'class': 'INDUSTRY'}]}}}