Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT00002056
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 Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral / Oral Trimethoprim - Sulfamethoxazole in the Treatment of Pneumocystis Carinii Pneumonia in AIDS
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': 'D017088', 'term': 'AIDS-Related Opportunistic 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': 'D009894', 'term': 'Opportunistic Infections'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010419', 'term': 'Pentamidine'}], 'ancestors': [{'id': 'D001550', 'term': 'Benzamidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1989-08', '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', 'AIDS-Related Opportunistic Infections', 'Pneumonia, Pneumocystis carinii', 'Pentamidine', 'Injections, Intravenous', 'Administration, Oral', 'Aerosols', 'Acquired Immunodeficiency Syndrome'], 'conditions': ['Pneumonia, Pneumocystis Carinii', 'HIV Infections']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Montgomery AB, Edison RE, Sattler F, Hopewell P, Mason G, Feigal DW. Aerosolized pentamidine vs. trimethoprim/sulfamethoxazole for acute Pneumcoystis carinii pneumonia (PCP): a randomized double blind trial. Int Conf AIDS. 1990 Jun 20-23;6(1):220 (abstract no ThB395)'}]}, 'descriptionModule': {'briefSummary': "This is a randomized double-blinded controlled study comparing aerosolized pentamidine with trimethoprim plus sulfamethoxazole (TMP / PurposeX). The latter drug will be administered intravenously for at least 5 days, then changed to oral administration if warranted by the patient's clinical condition."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Zidovudine as long as such therapy is suspended prior to randomization and not reinstituted until therapy for the acute episode is completed.\n\nPneumocystis carinii pneumonia (PCP) in an adult who is HIV positive by ELISA, HIV culture, or p24 antigenemia, or is a member of a risk group for HIV infection (homosexual or bisexual men, intravenous drug abusers, recipients of HIV infected blood products, and the sexual partners of the foregoing groups).\n\n* The patient must have a resting Alveolar - arterial oxygen (A-a) DO2 less than 30 mmHg on room air at all ACTG sites, except San Francisco General Hospital. Other sites will enter patients up to a resting (A-a) DO2 = or \\< 55 mmHg on room air.\n\nPrior Medication:\n\nAllowed:\n\n* Zidovudine as long as such therapy is suspended prior to randomization and not reinstituted until therapy for the acute episode is completed.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* Dyspnea.\n* Cough.\n* Bronchospasm.\n* History of a major adverse reaction to pentamidine or sulfonamide containing preparations.\n\nPatients with the following will be excluded:\n\n* Inability to cooperate with aerosol administration because of dyspnea, cough, bronchospasm, or other reasons.\n* History of a major adverse reaction to pentamidine or sulfonamide containing preparations.\n* In the opinion of the investigator, the patient would not complete therapy or follow-up for social reasons.\n\nPrior Medication:\n\nExcluded within 14 days of study entry:\n\n* Systemic steroids above adrenal replacement doses.\n* Excluded within 6 weeks of study entry:\n* Other antiprotozoal regimen for this episode such as trimethoprim / sulfamethoxazole (TMP / PurposeX).\n* Pyrimethamine.\n* Fansidar.\n* Pentamidine.\n* Eflornithine (DFMO).\n* Dapsone, whether therapeutic or prophylactic, or any of these agents.'}, 'identificationModule': {'nctId': 'NCT00002056', 'briefTitle': 'A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral / Oral Trimethoprim - Sulfamethoxazole in the Treatment of Pneumocystis Carinii Pneumonia in AIDS', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral / Oral Trimethoprim - Sulfamethoxazole in the Treatment of Pneumocystis Carinii Pneumonia in AIDS', 'orgStudyIdInfo': {'id': '023A'}, 'secondaryIdInfos': [{'id': '87-001'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Pentamidine isethionate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60018', 'city': 'Rosemont', 'state': 'Illinois', 'country': 'United States', 'facility': 'LyphoMed Inc', 'geoPoint': {'lat': 41.99531, 'lon': -87.88451}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LyphoMed', 'class': 'INDUSTRY'}}}}