Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT00000967
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Safety of Zidovudine Plus Interferon-Alpha in HIV-Infected Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D000077190', 'term': 'Interferon alpha-2'}, {'id': 'D015215', 'term': 'Zidovudine'}], 'ancestors': [{'id': 'D016898', 'term': 'Interferon-alpha'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '1996-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-28', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Drug Therapy, Combination', 'AIDS-Related Complex', 'Zidovudine', 'Interferon Type I'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Diaz C, Yogev R, Culnane M, Rogers A, Van Dyke R, Fenton T. ACTG 153: a multicenter phase I study of alpha-interferon in HIV infected children. AIDS Clinical Trials Group. Int Conf AIDS. 1994 Aug 7-12;10(1):79 (abstract no 269B)'}, {'type': 'BACKGROUND', 'citation': 'Clemente D, Yogev R, Culnane M, Rogers A, Van Dyke R, Hetherington S, Fenton T. ACTG 153: phase I, open-label; dose escalating study of interferon-alpha alone and in combination with zidovudine in children with early HIV disease. Program Abstr Intersci Conf Antimicrob Agents Chemother. 1994 Oct 4-7:35'}]}, 'descriptionModule': {'briefSummary': 'PRIMARY: To determine the maximum tolerated dose of interferon-alfa (IFN-A) alone and in combination with zidovudine (AZT); to assess the safety and tolerance of IFN-A alone and in combination with AZT.\n\nSECONDARY: To evaluate the effect of combination IFN-A and AZT on immunologic and virologic parameters; to determine whether the pharmacokinetic parameters of AZT are modified by the subcutaneous administration of IFN-A.\n\nAZT is effective in suppressing the progression of HIV infection in patients without symptoms or with AIDS or AIDS-related complex (ARC). However, use of AZT is limited by its frequent toxicity, which sometimes relates to the amount of drug given. Thus, a combination treatment of two drugs that work together may provide more effective and safer treatment. IFN-A is a drug that has antiviral effects and may work well with AZT.', 'detailedDescription': 'AZT is effective in suppressing the progression of HIV infection in patients without symptoms or with AIDS or AIDS-related complex (ARC). However, use of AZT is limited by its frequent toxicity, which sometimes relates to the amount of drug given. Thus, a combination treatment of two drugs that work together may provide more effective and safer treatment. IFN-A is a drug that has antiviral effects and may work well with AZT.\n\nThe study is being conducted in three stages. In Cohort A (IFN-A alone), four patients receive IFN-A; subsequent four-patient cohorts receive doses escalated in increments. If 50 percent or more of patients at any dose level experience grade 2 or better toxicity, doses in subsequent cohorts are escalated. If grade 3 or 4 toxicity is seen in one patient at a given dose level, two additional patients are enrolled at that level. Treatment is given subcutaneously (under the skin, with a needle), 3 times per week for 12 weeks. The MTD is defined as the dose level immediately below that at which 50 percent or more of patients experience grade 3 or 4 toxicity. In Cohort B (combination IFN-A plus AZT), patients who complete treatment in Cohort A continue on the same dose of IFN-A, and a low, middle, or high dose of AZT is added. In Cohort C, four newly assigned patients who have been on a stable prescribed dose of AZT of at least 90 mg/m2 for 6 weeks are treated at each of the same dose combinations as those in Cohort B. Treatment is given for 12 weeks. IFN-A is given subcutaneously 3 times a week and AZT is given orally every 6 hours. Dose levels of both drugs are increased until 50 percent or more of patients experience grade 3 or 4 toxicity in any dose level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nConcurrent Medication:\n\nRecommended:\n\n* Prophylaxis for Pneumocystis carinii pneumonia.\n\nAllowed:\n\n* Aerosol ribavirin for short-term treatment of acute respiratory syncytial virus (RSV).\n* Immunization according to the current recommendations of the Advisory Committee for Immunization Practice.\n* IVIG. Systemic ketoconazole, acyclovir, or oral nystatin for acute therapy.\n\nPatients must have the following:\n\n* HIV infection. Patients with proven resistance to AZT are also eligible.\n\nPrior Medication:\n\nAllowed:\n\n* Aerosol ribavirin.\n\nRequired:\n\nCohort C treatment:\n\n* Stable prescribed dose of zidovudine (AZT) \\>= 90 mg/m2 for at least 6 weeks prior to study entry.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded: AIDS or class P-2B, D, or E symptomatic infection.\n\nConcurrent Medication:\n\nExcluded:\n\n* Hepatotoxic or neurotoxic drugs, immunosuppressants, or antiseizure medication. Ketoconazole, fluconazole, and acyclovir for prophylaxis. Immunomodulators (other than IVIG). Experimental drugs.\n\nCohort A patients:\n\n* AZT for clinical indications.\n\nPrior Medication:\n\nExcluded:\n\n* Other antiretroviral agents (including didanosine (ddI), dideoxycytidine (ddC), or soluble CD4) within 1 month of study entry. Systemic ribavirin administered for retroviral therapy within 2 months of study entry.\n* Immunomodulating agents including interferon, isoprinosine, interleukin-2, or lymphocyte transfusions within 4 weeks of study entry.\n* RBC transfusion within 4 weeks prior to study entry.\n\nAlcohol or drug abuse.'}, 'identificationModule': {'nctId': 'NCT00000967', 'briefTitle': 'The Safety of Zidovudine Plus Interferon-Alpha in HIV-Infected Children', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Safety and Tolerance of Zidovudine and Interferon-Alpha in HIV-Infected Children', 'orgStudyIdInfo': {'id': 'ACTG 153'}, 'secondaryIdInfos': [{'id': '11128', 'type': 'REGISTRY', 'domain': 'DAIDS ES Registry Number'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Interferon alfa-2a', 'type': 'DRUG'}, {'name': 'Zidovudine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cook County Hosp.', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Chicago Children's CRS", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane/LSU Maternal/Child CRS', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'BMC, Div. of Ped Infectious Diseases', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Med. Ctr., Dept. of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'St. Jude/UTHSC CRS', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'city': 'Bayamón', 'country': 'Puerto Rico', 'facility': 'Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.', 'geoPoint': {'lat': 18.39856, 'lon': -66.15572}}, {'zip': '00936', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'San Juan City Hosp. PR NICHD CRS', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '00936', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Diaz C', 'role': 'STUDY_CHAIR'}, {'name': 'Yogev R', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'Glaxo Wellcome', 'class': 'INDUSTRY'}, {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}