Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT00002269
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen
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': 'C047490', 'term': 'poly(I).poly(c12,U)'}, {'id': 'D015215', 'term': 'Zidovudine'}], 'ancestors': [{'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1991-08', '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': ['Acquired Immunodeficiency Syndrome', 'ampligen', 'AIDS-Related Complex', 'Zidovudine'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'To evaluate ampligen at two dosage levels given twice weekly in combination with zidovudine (AZT) versus AZT alone in individuals with HIV-related immune dysfunction defined as T4 count between 100 and 300 cells/mm3.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nPatients must have:\n\n* HIV-1 seropositivity.\n* Absolute number of T4 cells 100-300 cells/mm3.\n* Given informed consent.\n* Zidovudine (AZT) therapy for 6 months prior to study entry.\n* At least one of the listed HIV-related clinical symptoms or opportunistic infections:\n* weight loss \\> 10 percent, unexplained diarrhea, unexplained intermittent fever, oral candidiasis \\> 1 month, decreased Karnofsky, oral hairy leukoplakia, chronic fatigue.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Evidence of AIDS.\n* Intercurrent acute medical disorder.\n\nConcurrent Medication:\n\nExcluded:\n\n* Chemotherapy for Kaposi's sarcoma (KS).\n* Aspirin.\n* Non-steroidal anti-inflammatory drugs.\n\nPatients with the following are excluded:\n\n* Inability to return for treatment and evaluation for 12 months.\n* Intercurrent acute medical disorder.\n* Evidence of AIDS.\n* Receiving chemotherapy for Kaposi's sarcoma (KS).\n* Unwilling or unable to give informed consent.\n\nRequired:\n\n* Zidovudine (AZT).\n\nRequired at least 6 months prior to study entry:\n\n* Zidovudine (AZT).\n\nActive drug abuse."}, 'identificationModule': {'nctId': 'NCT00002269', 'briefTitle': 'A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen', 'orgStudyIdInfo': {'id': '073A'}, 'secondaryIdInfos': [{'id': 'AMP-700'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Ampligen', 'type': 'DRUG'}, {'name': 'Zidovudine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Veterans Administration Med Ctr', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '97201', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health Sciences Univ', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19102', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'MCP Hahnemann Univ Hosp', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75219', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Nelson Tebedo Community Clinic', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Dr Patricia Salvato', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HEM Research', 'class': 'INDUSTRY'}}}}