Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT00002435
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 Study of Thymic Humoral Factor (THF Gamma 2) in HIV-Infected Patients
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': 'C014859', 'term': 'thymic humoral factor'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1998-02', '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', 'Antiviral Agents', 'Zidovudine', 'thymic humoral factor gamma 2'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'To investigate the safety of thymic humoral factor (THF gamma 2), its effect on HIV load based on at least a 75 percent decrease in HIV quantitative PCR RNA copies/ml, and its persistence when administered in combination with an antiretroviral nucleoside derivative (zidovudine; AZT). To assess the effects of THF gamma 2 on T-cells, quality of life, and progression of disease.', 'detailedDescription': 'All patients receive 12 weeks of AZT before being randomized to self-administer one of two doses of THF gamma 2 or placebo for 15 consecutive days and then twice weekly for an additional 50 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* AZT or another antiretroviral agent (marketed or investigational under a Treatment IND).\n* Primary prophylaxis for Pneumocystis carinii pneumonia (PCP), toxoplasmosis, and Mycobacterium avium-intracellulare (MAI) if patient's CD4 count decreases to \\< 200 cells/mm3.\n* Other marketed drugs as required.\n\nPatients must have:\n\n* HIV seropositivity and be either asymptomatic or have persistent generalized lymphadenopathy (PGL).\n* No history of symptoms in Category B or C of 1993 Case Definition, other than oral candidiasis following previous broad-spectrum antibiotic therapy.\n* Mean CD4 of 200-500 cells/mm3.\n* HIV-1 positive PCR RNA.\n* Ability to self-administer study drug by IM injection.\n* Ability to tolerate AZT at 600 mg daily during first 8 weeks of run-in period (if AZT naive) OR tolerated AZT at \\>= 500 mg daily for at least 3 months but no more than 12 months prior to randomization.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Malignancy.\n* Hematuria.\n* Proteinuria \\> 1+.\n\nConcurrent Medication:\n\nExcluded:\n\n* Non-antiretroviral agents with known or suspected activity against HIV.\n* Investigational new drugs that are not antiretroviral agents distributed under a Treatment IND.\n\nPatients with the following prior conditions are excluded:\n\nMyositis within the past 6 months.\n\nPrior Medication:\n\nExcluded:\n\n* Experimental therapy, including interleukin-2, interferon, erythropoietin, or filgrastim nucleoside within 6 weeks prior to study entry.\n* Prior antiretroviral therapy (AZT-naive patients only).\n\nPrior Treatment:\n\nExcluded within 6 weeks prior to study entry:\n\n* Blood transfusion or blood products. Active alcoholism, drug abuse, or a mental or psychiatric problem sufficient to prevent adequate compliance with study."}, 'identificationModule': {'nctId': 'NCT00002435', 'briefTitle': 'A Study of Thymic Humoral Factor (THF Gamma 2) in HIV-Infected Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'Study of the Activity of Thymic Humoral Factor (THF Gamma 2) on HIV Load in HIV-Positive Individuals With CD4+ Cell Counts in the Range of 200-500 Cells/mm3', 'orgStudyIdInfo': {'id': '136A'}, 'secondaryIdInfos': [{'id': 'CS 112010-999'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Thymic Humoral Factor', 'type': 'DRUG'}, {'name': 'Zidovudine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92717', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'UCI', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90028', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Southwest Community Based AIDS Treatment Group - COMBAT', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco Veterans Administration Med Ctr', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Gottlieb Med Group', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Mem Hosp Hollywood', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Goodgame Med Group', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '10014', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Chelsea Village Med Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Portland Veterans Adm Med Ctr / Rsch & Education Grp', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '29204', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Dr Alfred F Burnside Jr', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '22203', 'city': 'Annandale', 'state': 'Virginia', 'country': 'United States', 'facility': 'Infectious Disease Physicians Inc', 'geoPoint': {'lat': 38.83039, 'lon': -77.19637}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pharmacia', 'class': 'INDUSTRY'}}}}