Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-27 @ 1:19 AM
Study NCT ID:
NCT00002392
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 Thalidomide in HIV-Infected Patients Who Are Receiving HAART
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D013742', 'term': 'Tetanus'}], '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': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013792', 'term': 'Thalidomide'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1999-04', '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': ['Lymphocyte Transformation', 'Immunity, Cellular', 'Drug Therapy, Combination', 'Adjuvants, Immunologic', 'Thalidomide', 'Immunologic Memory', 'Streptococcus pneumoniae', 'Tetanus Toxoid', 'Pneumococcal Vaccines'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'To ascertain the effect of thalidomide on immune responses to vaccination with polyvalent pneumococcal polysaccharide vaccine and tetanus toxoid in HIV-infected patients; particularly, on markers of immune activation and parameters of specific, anti-HIV cellular immunity.', 'detailedDescription': 'Patients receive oral thalidomide in a blinded, placebo-controlled study. \\[AS PER AMENDMENT 11/25/98: This is a double-blind, placebo-controlled trial in which thalidomide or placebo is administered for 21 days. After the first week of therapy, patients receive immunizations with keyhole limpet hemocyanin and polyvalent pneumococcal vaccine. Study therapy is stopped for 2 weeks after the immunizations. Following the immunizations, detailed evaluations of the immune responses to the vaccines are conducted over the next 8 weeks.\\]'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatients must have:\n\n* Documented HIV infection.\n* CD4+ cell count between 300 and 500 cells/mm3.\n* HIV-1 RNA \\< 500 by the branched-chain DNA assay (bDNA assay, Chiron) within 21 days of study entry \\[AS PER AMENDMENT 11/25/98:\n* Undetectable-plasma HIV titers (as defined by the FDA) by the branched-chain DNA test\\].\n* Established B cell lines \\[deleted AS PER AMENDMENT 11/25/98\\].\n* Response to at least one recall antigen in an in vitro assay of lymphocyte proliferative responses.\n* Life expectancy \\> 6 months \\[deleted AS PER AMENDMENT 11/25/98\\].\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Active opportunistic infection or HIV-related malignancy \\[HIV-related malignancy deleted AS PER AMENDMENT 11/25/98\\].\n* Peripheral neuropathy of grade 2 or higher by Division of AIDS toxicity criteria.\n\nConcurrent Medication:\n\nExcluded:\n\n* Other investigational HIV-drugs.\n* Immunomodulatory or potentially immunomodulatory drugs, such as glucocorticoids, hematopoietins, interleukin-2, interferon, or pentoxifylline.\n\nPatients with the following prior conditions are excluded:\n\nHistory of serious hypersensitivity to tetanus toxoid or any of the vaccine components.\n\nPrior Medication:\n\nExcluded:\n\n* Previous immunization with pneumococcal polysaccharide vaccine \\[or, AS PER AMENDMENT 11/25/98, keyhole limpet hemocyanin vaccine\\].\n* Tetanus toxoid booster within 5 years \\[deleted AS PER AMENDMENT 11/25/98\\].\n* Other investigational HIV-drugs within 6 weeks of enrollment.\n* Immunomodulatory or potentially immunomodulatory drugs, such as glucocorticoids, hematopoietins, interleukin-2, interferon, or pentoxifylline within 6 weeks of enrollment.\n\nRisk Behavior:\n\nExcluded:\n\nActive drug or alcohol abuse.\n\nRequired:\n\nEffective combination antiretroviral therapy including two nucleoside analog agents (ZDV, 3TC, ddI, ddC, or d4T) and nelfinavir or indinavir, for at least one month prior to study entry. \\[AS PER AMENDMENT 11/25/98:\n\n* On stable, effective, highly-active antiretroviral therapy with combinations of any FDA-approved anti-HIV drugs for at least 3 months prior to entry.\\]'}, 'identificationModule': {'nctId': 'NCT00002392', 'briefTitle': 'A Study of Thalidomide in HIV-Infected Patients Who Are Receiving HAART', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Study to Investigate the Potential of Thalidomide Treatment to Enhance Immune Responses in HIV-Infected Individuals Who Are Receiving Highly Active Antiretroviral Therapy.', 'orgStudyIdInfo': {'id': '279A'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Thalidomide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rockefeller University', 'class': 'OTHER'}}}}