Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-25 @ 2:05 PM
Study NCT ID:
NCT00000666
Status:
COMPLETED
Last Update Posted:
2012-10-29
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma Gondii Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016781', 'term': 'Toxoplasmosis, Cerebral'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D014123', 'term': 'Toxoplasmosis'}, {'id': 'D017088', 'term': 'AIDS-Related Opportunistic Infections'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D001922', 'term': 'Brain Abscess'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020808', 'term': 'Central Nervous System Protozoal Infections'}, {'id': 'D020807', 'term': 'Central Nervous System Parasitic Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D003048', 'term': 'Coccidiosis'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D000038', 'term': 'Abscess'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System 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': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011739', 'term': 'Pyrimethamine'}], 'ancestors': [{'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '1992-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-26', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2012-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Toxoplasmosis', 'AIDS-Related Opportunistic Infections', 'Pyrimethamine', 'Drug Evaluation', 'Encephalitis', 'Acquired Immunodeficiency Syndrome'], 'conditions': ['Toxoplasmosis, Cerebral', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '1676364', 'type': 'BACKGROUND', 'citation': 'Jacobson MA, Besch CL, Child C, Hafner R, Muth K, Deyton L. Clinical programs for clinical research on AIDS: description of a randomized prospective study of clindamycin versus pyrimethamine for prevention of Toxoplasma gondii infection. Eur J Clin Microbiol Infect Dis. 1991 Mar;10(3):195-8. doi: 10.1007/BF01964462.'}, {'pmid': '1346413', 'type': 'BACKGROUND', 'citation': 'Jacobson MA, Besch CL, Child C, Hafner R, Matts JP, Muth K, Wentworth DN, Deyton L. Toxicity of clindamycin as prophylaxis for AIDS-associated toxoplasmic encephalitis. Community Programs for Clinical Research on AIDS. Lancet. 1992 Feb 8;339(8789):333-4. doi: 10.1016/0140-6736(92)91649-s.'}, {'pmid': '8106772', 'type': 'BACKGROUND', 'citation': 'Jacobson MA, Besch CL, Child C, Hafner R, Matts JP, Muth K, Wentworth DN, Neaton JD, Abrams D, Rimland D, et al. Primary prophylaxis with pyrimethamine for toxoplasmic encephalitis in patients with advanced human immunodeficiency virus disease: results of a randomized trial. Terry Beirn Community Programs for Clinical Research on AIDS. J Infect Dis. 1994 Feb;169(2):384-94. doi: 10.1093/infdis/169.2.384.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate pyrimethamine as a prophylactic agent against toxoplasmic encephalitis in individuals who are coinfected with HIV and latent Toxoplasma gondii.\n\nToxoplasmic encephalitis is a major cause of illness and death in AIDS patients. Standard treatment for toxoplasmic encephalitis is to combine pyrimethamine and sulfadiazine. Continuous treatment is necessary to prevent recurrence of the disease, but constant use of pyrimethamine/sulfadiazine is associated with toxicity. Clindamycin has been shown to be effective in treatment of toxoplasmic encephalitis in animal studies. This study evaluates pyrimethamine as a preventive treatment against toxoplasmic encephalitis (per 3/26/91 amendment, clindamycin arm was discontinued).', 'detailedDescription': 'Toxoplasmic encephalitis is a major cause of illness and death in AIDS patients. Standard treatment for toxoplasmic encephalitis is to combine pyrimethamine and sulfadiazine. Continuous treatment is necessary to prevent recurrence of the disease, but constant use of pyrimethamine/sulfadiazine is associated with toxicity. Clindamycin has been shown to be effective in treatment of toxoplasmic encephalitis in animal studies. This study evaluates pyrimethamine as a preventive treatment against toxoplasmic encephalitis (per 3/26/91 amendment, clindamycin arm was discontinued).\n\nPatients are randomized to receive pyrimethamine or placebo three times a week. All patients must be on aerosolized pentamidine, trimethoprim / sulfamethoxazole (T/S), or dapsone for Pneumocystis carinii pneumonia prophylaxis. Patients will be evaluated bi-weekly for the first month and every other month thereafter for at least 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nConcurrent Medication:\n\nRequired:\n\n* Prophylactic treatment for Pneumocystis carinii pneumonia with aerosolized pentamidine, dapsone, or trimethoprim / sulfamethoxazole.\n\nAllowed:\n\n* Most medications not specifically excluded.\n\nPrior Medication:\n\nAllowed:\n\n* Antivirals.\n* Antiretrovirals.\n\nPatients:\n\n* Must be HIV positive or have an AIDS-defining illness OR be at known risk for HIV infection and have a CD4 cell count \\< 200/mm3 and no other known immunosuppressive disease.\n* Must have positive titer for Toxoplasma gondii.\n* Must be or become a patient of a CPCRA physician.\n* May participate in other clinical trials as long as there is no potential activity against Toxoplasma gondii or cross-toxicity among study drugs.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* History of ocular, pulmonary, or central nervous system (CNS) toxicity.\n* CNS lesions.\n* Neurologic deficits except peripheral neuropathy.\n* Mild, moderate, severe, or end-stage AIDS dementia complex. Grade 3 or higher nausea and/or vomiting.\n* Sensitivity to pyrimethamine.\n\nConcurrent Medication:\n\nExcluded:\n\n* On-going therapy with clindamycin, fansidar, methotrexate, trimetrexate, spiramycin, azithromycin, clarithromycin, 566C80, and/or sulfa agents other than anti-PCP agents.\n\nPatients with the following are excluded:\n\n* History of ocular, pulmonary, or central nervous system (CNS) toxicity.\n* CNS lesions or history of CNS lesions.\n* Neurologic deficits except peripheral neuropathy.\n* Mild, moderate, severe, or end-stage AIDS dementia complex. Grade 3 or higher nausea and/or vomiting.\n* Sensitivity to pyrimethamine.'}, 'identificationModule': {'nctId': 'NCT00000666', 'briefTitle': 'A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma Gondii Infection', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma Gondii Infection', 'orgStudyIdInfo': {'id': 'CPCRA 001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pyrimethamine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Community Consortium of San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '802044507', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver CPCRA / Denver Public Hlth', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hill Health Corp', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '19899', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Wilmington Hosp / Med Ctr of Delaware', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'AIDS Research Consortium of Atlanta', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'AIDS Research Alliance - Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana Comm AIDS Rsch Prog / Tulane Univ Med', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Comprehensive AIDS Alliance of Detroit', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hosp', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '071032842', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'North Jersey Community Research Initiative', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '11201', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Addiction Research and Treatment Corp', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Clinical Directors Network of Region II', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10037', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Harlem AIDS Treatment Group / Harlem Hosp Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10456', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Bronx Lebanon Hosp Ctr', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '972109951', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Portland Veterans Adm Med Ctr / Rsch & Education Grp', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Richmond AIDS Consortium', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Jacobson M', 'role': 'STUDY_CHAIR'}, {'name': 'Besch CL', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}}}}