Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-25 @ 2:32 PM
Study NCT ID:
NCT00000650
Status:
COMPLETED
Last Update Posted:
2021-10-27
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Assessment of the In Vivo Biological Effects of Diethyldithiocarbamate (DTC) in HIV-Infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], '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': 'D004050', 'term': 'Ditiocarb'}], 'ancestors': [{'id': 'D013859', 'term': 'Thiocarbamates'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '1996-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-26', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Drug Evaluation', 'Ditiocarb', 'Acquired Immunodeficiency Syndrome'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'To determine, in HIV-infected patients, the magnitude and duration of the biological effects of ditiocarb sodium (sodium diethyldithiocarbamate; DTC) that may be relevant to treatment of HIV infection.\n\nDTC has been studied in previous clinical trials in HIV-infected patients with the suggestion of delay in disease progression to AIDS and improvement in CD4 counts while on the drug.', 'detailedDescription': 'DTC has been studied in previous clinical trials in HIV-infected patients with the suggestion of delay in disease progression to AIDS and improvement in CD4 counts while on the drug.\n\nTwo groups of patients, one group asymptomatic and the other with AIDS diagnosis, are enrolled in the study. All patients receive DTC intravenously once a week for two weeks. Drugs are given on days 1 and 8. Blood samples are drawn on days 1, 3, 5, 8, 10, and 12.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nPatients must:\n\n* Have HIV infection.\n* Be asymptomatic (group 1) or have AIDS (group 2).\n* Be able to understand and follow instructions.\n\nConcurrent Medication:\n\nAllowed:\n\nGROUP 2:\n\n* Anti-HIV therapy.\n* Systemic prophylaxis or maintenance therapy for any AIDS-defining opportunistic infection excluding agents considered immunomodulators or immunosuppressants.\n* Topical nystatin.\n* Clotrimazole troches.\n* Acyclovir.\n* Dapsone.\n* Trimethoprim / sulfamethoxazole (T/S).\n* Fluconazole.\n* Ketoconazole.\n* Aerosolized pentamidine.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\nALL PATIENTS:\n\n* Known hypersensitivity to disulfiram or diethyldithiocarbamate (DTC).\n* Transfusion dependence.\n\nGROUP 1 PATIENTS ONLY:\n\n* Oral candidiasis documented by morphology or by a response to antifungal therapy.\n* Oral hairy leukoplakia.\n* Occurrence of herpes zoster in a single dermatomal distribution.\n* Recurrent seborrheic dermatitis.\n* Unintentional weight loss in excess of 10 pounds or 10 percent of usual body weight within 2 years prior to study.\n* Unexplained temperature above 38 degrees C on more than 5 consecutive days or on more than 10 days in any 30 days within 2 years of expected study entry.\n* Unexplained diarrhea defined by two or more stools/day for at least 14 days during a 120-day interval.\n* Evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, renal, or dermatologic disease as demonstrated by history, physical, and laboratory evaluation.\n\nGROUP 2 PATIENTS ONLY:\n\n* Concurrent neoplasms other than Kaposi's sarcoma or basal cell carcinoma of the skin.\n* Diagnosis of an acute opportunistic infection within 3 weeks of study entry or had treatment initiated for an opportunistic infection within 3 weeks of study entry.\n\nConcurrent Medication:\n\nExcluded:\n\nALL PATIENTS:\n\n* Recombinant erythropoietin.\n\nGROUP 1:\n\n* Antiretroviral medications.\n\nGROUP 2:\n\n* Immunomodulators or immunosuppressants.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Requirement for blood transfusions more than once a month.\n\nPatients with the following prior conditions are excluded:\n\nGROUP 1 PATIENTS ONLY:\n\n* Oral candidiasis documented by morphology or by a response to antifungal therapy.\n* Oral hairy leukoplakia.\n* Occurrence of herpes zoster in a single dermatomal distribution.\n* Recurrent seborrheic dermatitis.\n* Unintentional weight loss in excess of 10 pounds or 10 percent of usual body weight within 2 years prior to study.\n* Unexplained temperature above 38 degrees C on more than 5 consecutive days or on more than 10 days in any 30-day period within 2 years of expected study entry.\n* Unexplained diarrhea defined by two or more stools/day for at least 14 days during a 120-day interval.\n* Evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, renal, or dermatologic disease as demonstrated by history, physical, and laboratory evaluation.\n\nGROUP 2 PATIENTS ONLY:\n\n* Diagnosis of an acute opportunistic infection within 3 weeks of study entry or had treatment initiated for an opportunistic infection within 3 weeks of study entry.\n\nPrior Medication:\n\nExcluded:\n\nALL PATIENTS:\n\n* Corticosteroids, cytotoxic agents, or immunomodulating agents within 30 days prior to study entry.\n* Chronic Antabuse (disulfiram) therapy.\n\nGROUP 1 ONLY:\n\n* Antiretrovial medications within 1 week prior to study entry.\n\nPrior Treatment:\n\nExcluded:\n\n* Transfusion within 7 days of study entry.\n* Radiation therapy within 30 days prior to study entry.\n\nUnable to refrain from the use of alcohol for the duration of the study."}, 'identificationModule': {'nctId': 'NCT00000650', 'briefTitle': 'An Assessment of the In Vivo Biological Effects of Diethyldithiocarbamate (DTC) in HIV-Infected Patients', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'An Assessment of the In Vivo Biological Effects of Diethyldithiocarbamate (DTC) in HIV-Infected Patients', 'orgStudyIdInfo': {'id': 'ACTG 166'}, 'secondaryIdInfos': [{'id': '11141', 'type': 'REGISTRY', 'domain': 'DAIDS ES Registry Number'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Ditiocarb sodium', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Adult AIDS CRS', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'PS Lietman', 'role': 'STUDY_CHAIR'}, {'name': 'P Barditch-Crovo', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'Connaught Laboratories', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}