Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-25 @ 8:07 AM
Study NCT ID:
NCT00002332
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 of Timunox (Thymopentin) in HIV-Infected Patients Receiving Other Anti-HIV Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D016305', 'term': 'Thymopentin'}], 'ancestors': [{'id': 'D013946', 'term': 'Thymopoietins'}, {'id': 'D013951', 'term': 'Thymus Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1995-12', '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': ['Thymopentin', 'AIDS-Related Complex'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'To evaluate the mechanism whereby thymopentin appears to retard the progressive immune suppression attributable to HIV infection.', 'detailedDescription': 'Patients are randomized to receive subcutaneous thymopentin or placebo thrice weekly for 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatients must have:\n\n* Asymptomatic or minimally symptomatic HIV infection (no evidence of AIDS).\n* CD4 count \\<= 400 cells/mm3 within 6 weeks prior to study entry (CD4 count changed to 100 - 400 cells/mm3 per amendment).\n* Tolerated the current nucleoside analog antiretroviral treatment for at least 4 weeks prior to study entry.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Known hypersensitivity to thymopentin or any component of the formulation.\n* Significant chronic underlying medical illness that would impede study participation.\n* Grade 2 or higher peripheral neuropathy related to nucleoside analog antiretroviral treatment.\n\nConcurrent Medication:\n\nExcluded:\n\n* Any antiretroviral agents other than zidovudine, didanosine, or dideoxycytidine.\n* HIV vaccines or any investigational or non-FDA approved medication or immunomodulatory or experimental therapy within 30 days prior to study entry.\n\nPatients with the following prior condition are excluded:\n\nAbnormal chest x-ray consistent with active opportunistic infection within 6 weeks prior to study entry.\n\nPrior Medication:\n\nExcluded:\n\n* Any prior antiretroviral agents other than zidovudine, didanosine, or dideoxycytidine within 30 days prior to study entry.\n\nRequired:\n\n* Current nucleoside analog antiretroviral treatment.\n\nRequired:\n\n* Nucleoside analog antiretroviral treatment for at least 4 weeks prior to study entry.\n\nSignificant active alcohol or drug abuse sufficient to prevent study compliance.'}, 'identificationModule': {'nctId': 'NCT00002332', 'briefTitle': 'A Study of Timunox (Thymopentin) in HIV-Infected Patients Receiving Other Anti-HIV Drugs', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'Double-Blind Study of the Effect of Timunox (Thymopentin) on Lymphoproliferative Responses and Virus Load in HIV-Infected Subjects Receiving Nucleoside Analog Antiretroviral Therapy', 'orgStudyIdInfo': {'id': '015I'}, 'secondaryIdInfos': [{'id': '07.32.039-94'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Thymopentin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Dr Marcus Conant', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '91356', 'city': 'Tarzana', 'state': 'California', 'country': 'United States', 'facility': 'Dr Jeffrey Galpin', 'geoPoint': {'lat': 34.17334, 'lon': -118.55397}}, {'zip': '15206', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Novum Inc', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Immunobiology Research Institute', 'class': 'INDUSTRY'}}}}