Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT00002018
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, Randomized, Dose Ranging Study of Alferon LDO (Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)) in HIV+ Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C554126', 'term': 'Interferon Alfa-n3'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1993-03', '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': ['Interferon Type I'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'To conduct a double-blind, randomized, dose ranging study of an orally administered low dose interferon alfa-n3 (IFN-An3) immunomodulator in the treatment of symptomatic HIV+ subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Zidovudine (AZT).\n* Didanosine (ddI)\n\nPatients must have:\n\n* Seropositivity to HIV-1 by ELISA and Western blot.\n* At least 1 of the HIV-related clinical symptoms or opportunistic infections listed in protocol.\n* Written informed consent.\n* If already on zidovudine (AZT) or didanosine (ddI), must have been on this therapy for at least 75 of the 90 days prior to study entry.\n\nPrior Medication:\n\nAllowed:\n\n* Zidovudine (AZT).\n* Didanosine (ddI)\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Major active opportunistic infection requiring active care within 2 weeks of study entry.\n* Evidence of chronic hepatitis with severe liver dysfunction:\n* albumin \\< 2 g/dl and SGOT or SGPT \\> 5 x upper limit of normal prothrombin time \\> 1.5 x upper limit of normal).\n* Other active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular, neurologic, or psychiatric disorder.\n* Transfusion dependency defined as requiring \\> 1 unit of packed red blood cells (RBC) per month within 3 months prior to study entry.\n\nConcurrent Medication:\n\nExcluded:\n\n* Experimental medications other than didanosine (ddI).\n* Chronic prophylactic use of any topical or systemic fungal medication such as ketoconazole, fluconazole, or clotrimazole.\n* Chronic prophylactic use of any topical or systemic anti-viral medication such as acyclovir or ganciclovir except zidovudine (AZT) or didanosine (ddI).\n\nPatients with the following are excluded:\n\n* Asymptomatic at study entry.\n* Presence of antibodies to interferon due to prior therapy.\n* Hospitalization within 2 weeks of study entry.\n* Transfusion dependency.\n* Unwilling or unable to give informed consent.\n* Evidence of any concurrent organ dysfunction listed in Exclusion Co-Existing Conditions.\n* Unlikely or unable to comply with the requirements of the protocol.\n\nPrior Medication:\n\nExcluded within 6 weeks of study entry:\n\n* Interferons.\n* Excluded within 45 days of study entry:\n* Immunosuppressive agents.\n* Chemotherapy.\n* Steroids.\n* Immunomodulators.\n* Isoprinosine.\n* BCG vaccine.\n\nPrior Treatment:\n\nExcluded within 2 weeks of study entry:\n\n* Hospitalization.\n\nActive intravenous (IV) drug abuse.'}, 'identificationModule': {'nctId': 'NCT00002018', 'briefTitle': 'Double-Blind, Randomized, Dose Ranging Study of Alferon LDO (Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)) in HIV+ Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'Double-Blind, Randomized, Dose Ranging Study of Alferon LDO (Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)) in HIV+ Subjects', 'orgStudyIdInfo': {'id': '069B'}, 'secondaryIdInfos': [{'id': '90-355ME'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Interferon alfa-n3', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Med Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Interferon Sciences', 'class': 'INDUSTRY'}}}}