Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2025-12-27 @ 3:03 AM
Study NCT ID:
NCT00002059
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 Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D007542', 'term': 'Inosine Pranobex'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D007288', 'term': 'Inosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1989-06', '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': ['T-Lymphocytes, Suppressor-Effector', 'Neoplasms', 'Inosine Pranobex', 'Killer Cells', 'T-Lymphocytes, Helper-Inducer', 'Acquired Immunodeficiency Syndrome', 'AIDS-Related Complex'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The objective of this double-blind placebo-controlled study is to evaluate the effect of Isoprinosine in a group of homogenous male volunteers who present with immunologic defects relative to:\n\n* Comparison of total helper and suppressor T-cell number between the groups.\n* Comparison of the phytohemagglutinins (PHA) and concanavalin A lymphoproliferative response and natural killer (NK) cell activity between the groups.\n* Determination of the clinical course of the volunteers after discontinuance of Isoprinosine.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Exclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* Opportunistic infections or Kaposi's sarcoma.\n* Critical illness.\n* History of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer.\n\nConcurrent Medication:\n\nExcluded:\n\n* Steroids.\n* Cytotoxic immunosuppressive agents.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Radiotherapy.\n\nThe following are excluded:\n\n* Opportunistic infections or Kaposi's sarcoma.\n* Critically ill patients.\n* Patients receiving steroids, cytotoxic immunosuppressive agents, and/or radiotherapy.\n* Patients who have received any other immunotherapy.\n* Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer.\n\nPrior Medication:\n\nExcluded:\n\n* Any other immunotherapy.\n\nPatients who fall into the group which is at risk of developing cutaneous sarcoma and/or opportunistic diseases but at present have no signs or symptoms of these diseases."}, 'identificationModule': {'nctId': 'NCT00002059', 'briefTitle': 'A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers', 'orgStudyIdInfo': {'id': '008E'}, 'secondaryIdInfos': [{'id': 'ISO-133-USA'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Inosine pranobex', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92656', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Newport Pharmaceuticals International Inc', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Newport Pharmaceuticals International', 'class': 'INDUSTRY'}}}}