Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2026-01-01 @ 1:20 PM
Study NCT ID:
NCT00002266
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients
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': 'C054105', 'term': "ammonium trichloro(dioxoethylene-O,O'-)tellurate"}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1990-12', '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': ['Drug Therapy, Combination', 'Acquired Immunodeficiency Syndrome', 'AIDS-Related Complex', "ammonium trichloro(dioxoethylene-O,O'-)tellurute"], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'To compare AS-101 dosing schedules (once a week; 3 times a week; 5 times a week; or 5 times per week on alternate weeks) on the effect on clinical immunology and virus burden in AIDS or AIDS related complex (ARC) patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Standard therapy for infections.\n* Acyclovir.\n* Ganciclovir.\n* Allowed only with permission of Wyeth-Ayerst medical monitor:\n* Zidovudine (AZT).\n* Immunomodulators.\n* Specific therapy for malignancies (including Kaposi's sarcoma).\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Evidence of severe liver dysfunction (serum albumin \\< 3 g/dl, SGOT or SGPT \\> 5 x upper limit of normal, prothrombin time \\> 15 seconds), or gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular system abnormalities or psychiatric disorder other than abnormalities secondary to AIDS or AIDS related complex (ARC).\n* Evidence of AIDS-related central nervous system involvement.\n* Disseminated Kaposi's sarcoma.\n\nConcurrent Medication:\n\nExcluded without permission of Wyeth-Ayerst medical monitor:\n\n* Zidovudine (AZT).\n* Immunomodulators.\n* Specific therapy for malignancies (including Kaposi's sarcoma).\n\nPatients with the following are excluded:\n\n* Evidence of major system abnormalities other than abnormalities secondary to AIDS or AIDS related complex.\n* Concomitant conditions as specified in Patient Exclusion Co-existing Conditions.\n* Unlikely or unable to comply with the requirements of the protocol.\n\nPrior Medication:\n\nExcluded within 4 weeks of study entry:\n\n* Systemic antiviral agents.\n* Immunosuppressive agents.\n* Immune stimulators such as BCG vaccine, isoprinosine, or other immunomodulators.\n\nPatients must:\n\n* Have a diagnosis of AIDS or AIDS related complex (ARC).\n* Demonstrate intolerance or refusal to take zidovudine (AZT).\n* Provide written informed consent."}, 'identificationModule': {'nctId': 'NCT00002266', 'briefTitle': 'An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients', 'orgStudyIdInfo': {'id': '045B'}, 'secondaryIdInfos': [{'id': '753A-103-US'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'AS-101', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Univ of Arizona / Health Science Ctr', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}}}}