Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 4:48 AM
Study NCT ID:
NCT00000833
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.
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': 'D012254', 'term': 'Ribavirin'}, {'id': 'D016049', 'term': 'Didanosine'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D007288', 'term': 'Inosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '1998-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-27', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Ribavirin', 'Didanosine', 'Drug Therapy, Combination', 'Acquired Immunodeficiency Syndrome', 'AIDS-Related Complex', 'Antiviral Agents'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'McKinney RE Jr. Ongoing and future trials of antiretroviral therapy in the pediatric AIDS clinical trials group (PACTG). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:173'}]}, 'descriptionModule': {'briefSummary': 'To compare the safety, toxicity, and tolerance of two doses of ribavirin in combination with didanosine (ddI) to HIV-infected children. To determine the toxicity of ddI/ribavirin and compare it to the expected toxicity of ddI monotherapy. To determine the effect of concurrent ribavirin on the pharmacokinetics of ddI. To determine a dosage of ribavirin that would be suitable for a Phase II/III evaluation of ddI/ribavirin.\n\nRibavirin, a broad spectrum antiviral agent, may enhance the antiretroviral activity of didanosine ( ddI ) without a concomitant increase in toxicity. Ribavirin alters the intracellular metabolism of ddI, enhancing the antiretroviral activity of the active form of ddI.', 'detailedDescription': 'Ribavirin, a broad spectrum antiviral agent, may enhance the antiretroviral activity of didanosine ( ddI ) without a concomitant increase in toxicity. Ribavirin alters the intracellular metabolism of ddI, enhancing the antiretroviral activity of the active form of ddI.\n\nPatients are divided into two cohorts. Subjects will be stratified by age 3 months to \\< 24 months and \\>= 24 months to 12 years. Fifty % of patients from each age group will be assigned to each cohort. Cohort 1 receives ddI monotherapy for 4 weeks, followed by combination ddl/ribavirin therapy for an additional 20 weeks. Cohort 2 receives combination ddI/ribavirin for 24 weeks. In both cohorts, after study medications are stopped, patients are treated with prescription antiretrovirals for 4 more weeks. \\[AS PER AMENDMENT 7/2/96: Note: In each cohort of 10 subjects at least 2 of 5 children from the older half of the cohort will have an ICD p24 antigen at entry.\\]'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nConcurrent Medication:\n\nRecommended:\n\n* PCP prophylaxis.\n\nAllowed:\n\n* Acetaminophen for no more than 72 hours.\n* Immunoglobulin.\n* Corticosteroids.\n* Erythropoietin.\n* G-CSF and GM-CSF.\n* Ethionamide or isoniazid for TB if no alternative available.\n* Immunizations according to current recommendations.\n\nPatients must have:\n\n* HIV infection.\n* Immunologic abnormality or clinical symptoms as detailed in the Disease Status field.\n* No active AIDS-defining opportunistic infection or malignancy, no progressive encephalopathy attributable to HIV and no chronic persistent diarrhea.\n* Consent of parent or guardian.\n\nPER AMENDMENT 7/2/96:\n\n* At least 2 of the 5 children in the older half of each cohort must have an ICD p24 antigen concentration \\>= 70 pg/ml at screening.\n\nPrior Medication:\n\nAllowed:\n\n* Up to 6 weeks of prior immunomodulator therapy.\n* Maternal immunomodulator or antiretroviral therapy, including during pregnancy.\n* Prior corticosteroids or intravenous immunoglobulin.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Current grade 3 or worse neuropathy/lower motor neuropathy.\n* Clinical or laboratory grade 3 or worse toxicities.\n* Active serious bacterial infection.\n\nConcurrent Medication:\n\nExcluded:\n\n* Chemotherapy for active malignancy.\n* Antiretrovirals other than study drugs.\n* Immunomodulators unless specifically allowed.\n\nPatients with the following prior condition are excluded:\n\n* History of grade 3 or worse neuropathy/lower motor neuropathy.\n\nPrior Medication:\n\nExcluded:\n\n* Prior ddI or oral ribavirin.\n* Aerosolized ribavirin within 6 weeks prior to study entry.\n* Antiretroviral or immunomodulator therapy (other than corticosteroids or IVIG) within 1 week prior to blood draws for study entry.\n\nOngoing drug or alcohol abuse.'}, 'identificationModule': {'nctId': 'NCT00000833', 'briefTitle': 'A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.', 'orgStudyIdInfo': {'id': 'ACTG 274'}, 'secondaryIdInfos': [{'id': '11250', 'type': 'REGISTRY', 'domain': 'DAIDS ES Registry Number'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Ribavirin', 'type': 'DRUG'}, {'name': 'Didanosine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200102916', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's Hosp of Washington DC", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20060', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Howard Univ Hosp', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ of Florida Health Science Ctr / Pediatrics', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '701122699', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane Univ / Charity Hosp of New Orleans', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '021155724', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hosp of Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '071032714', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Univ of Medicine & Dentistry of New Jersey / Univ Hosp', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '071072198', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': "Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl", 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': "Schneider Children's Hosp", 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia Presbyterian Med Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Incarnation Children's Ctr / Columbia Presbyterian Med Ctr", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10037', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Harlem Hosp Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10457', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Bronx Lebanon Hosp Ctr', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27709', 'city': 'Research Triangle Park', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Glaxo Wellcome Inc', 'geoPoint': {'lat': 35.89709, 'lon': -78.86029}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hosp / Baylor Univ", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '009365067', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': "Univ of Puerto Rico / Univ Children's Hosp AIDS", 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Van Dyke R', 'role': 'STUDY_CHAIR'}, {'name': 'McSherry G', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}