Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT00002051
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Double Blind Study of Thymopentin Effects on Patients With HIV-1 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'}], '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1989-11', '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', 'Acquired Immunodeficiency Syndrome'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'Examine the ability of thymopentin (Timunox) to:\n\nReduce the amount and/or frequency of virus isolation. Stimulate the immune system and alter the clinical findings in patients infected with HIV who do not yet have AIDS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nConcurrent Treatment:\n\nAllowed:\n\n* Aerosolized pentamidine.\n\nPrior Medication:\n\nAllowed:\n\n* Aerosolized pentamidine.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* AIDS as defined by the CDC (except for those with HIV "wasting syndrome").\n* Significant hepatic disease.\n* Thrombocytopenia (\\< 75000 platelets/mm3).\n* Abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to entry.\n* Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products.\n* Known hypersensitivity to thymopentin.\n\nPrior Medication:\n\nExcluded within 30 days of study entry:\n\n* Immunomodulatory or experimental therapy.\n* Excluded within 90 days of study entry:\n* Zidovudine (AZT).\n\nPatients must not have:\n\n* AIDS as defined by the CDC (except for those with HIV "wasting syndrome").\n* Significant hepatic disease.\n* Thrombocytopenia (\\< 75000 platelets/mm3).\n\nPatients with the following conditions are included:\n\n* Seropositive for HIV-1 (ELISA assay) confirmed by Western blot.\n* HIV-1 p24 antigen must be detected in supernatant fluids from co-cultures of patient\'s peripheral blood monocytes (PBMC) on two separate occasions.\n* HIV "wasting syndrome".\n* Must voluntarily sign consent.\n\nHistory of intravenous drug abuse.'}, 'identificationModule': {'nctId': 'NCT00002051', 'briefTitle': 'Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection', 'orgStudyIdInfo': {'id': '015E'}, 'secondaryIdInfos': [{'id': 'H87-101'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Thymopentin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '088010999', 'city': 'Annandale', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Immunobiology Research Institute', 'geoPoint': {'lat': 40.64093, 'lon': -74.88128}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Immunobiology Research Institute', 'class': 'INDUSTRY'}}}}