Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-26 @ 1:22 PM
Study NCT ID:
NCT00002092
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 to Evaluate the Effect of Cimetidine on CD4 Lymphocyte Counts in HIV Infection
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'}, {'id': 'D000386', 'term': 'AIDS-Related Complex'}], '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': 'D002927', 'term': 'Cimetidine'}], 'ancestors': [{'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, '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': ['Acquired Immunodeficiency Syndrome', 'AIDS-Related Complex', 'Cimetidine'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '8922801', 'type': 'BACKGROUND', 'citation': 'Cohen CJ, Hellinger JA, Day J, Salitsky N, Shevitz A, Zackin R, DeGruttola V. Lack of effect of cimetidine on lymphocyte subsets in patients infected with human immunodeficiency virus type 1. Clin Infect Dis. 1996 Nov;23(5):1049-54. doi: 10.1093/clinids/23.5.1049.'}]}, 'descriptionModule': {'briefSummary': 'To determine the change in CD4 count after 4 and 8 weeks in HIV-infected patients treated with cimetidine compared to placebo. To observe time-associated trends at weeks 4, 8, 12, and 16 in the change of CD4 counts for patients taking cimetidine for the full 16 weeks. To establish a safety record for cimetidine use in HIV-positive patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nConcurrent Medication:\n\nAllowed:\n\n* All FDA-approved medications, antiretrovirals, and PCP prophylaxis drugs, with the exception of warfarin (Coumadin).\n* Other self-prescribed medications available either over the counter or through buyer's clubs.\n\nPatients must have:\n\nHIV positivity.\n\nNOTE:\n\n* Patients on an antiviral or immunomodulating drug must have received it for at least 2 months and have no intention to make clinical or therapeutic changes in the first 8 weeks (such as adding a new agent or discontinuing effective viral suppressive therapy) that may interfere with the study.\n\nNOTE:\n\n* Patients who become pregnant after enrollment will be permitted to continue on study drug but must sign an additional informed consent indicating their awareness of the issues in taking a drug with limited safety data during pregnancy.\n\nPrior Medication:\n\nAllowed:\n\n* Antiviral and immunomodulating drugs, provided patient has been on such therapy for at least 2 months prior to study entry.\n\nExclusion Criteria:\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Known intolerance or hypersensitivity to cimetidine.\n* Evidence of active opportunistic infection or malignancy requiring high-dose systemic chemotherapy.\n* Any symptoms suggestive of concurrent illness that are not attributable to overall impairment by HIV or are not diagnosable based on the available evidence.\n* Inability to swallow tablets (gastric feeding tubes are allowed).\n* Not willing to comply with visit schedule and study procedures.\n\nConcurrent Medication:\n\nExcluded:\n\n* Warfarin (Coumadin).\n\nPrior Medication:\n\nExcluded within 4 weeks prior to study entry:\n\n* cimetidine (Tagamet), ranitidine (Zantac), famotidine (Pepcid), and nizatidine (Axid)."}, 'identificationModule': {'nctId': 'NCT00002092', 'briefTitle': 'A Study to Evaluate the Effect of Cimetidine on CD4 Lymphocyte Counts in HIV Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Study to Evaluate the Effect of Cimetidine on CD4 Lymphocyte Counts in HIV Infection', 'orgStudyIdInfo': {'id': '119A'}, 'secondaryIdInfos': [{'id': '92-01'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Cimetidine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02445', 'city': 'Brookline', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'CRI of New England', 'geoPoint': {'lat': 42.33176, 'lon': -71.12116}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Community Research Initiative of New England', 'class': 'OTHER'}}}}