Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT00000827
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '1998-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-27', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Acquired Immunodeficiency Syndrome', 'AIDS-Related Complex', 'Immunoglobulins, Intravenous', 'Immunization, Passive'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '10669338', 'type': 'BACKGROUND', 'citation': 'Stiehm ER, Fletcher CV, Mofenson LM, Palumbo PE, Kang M, Fenton T, Sapan CV, Meyer WA, Shearer WT, Hawkins E, Fowler MG, Bouquin P, Purdue L, Sloand EM, Nemo GJ, Wara D, Bryson YJ, Starr SE, Petru A, Burchett S. Use of human immunodeficiency virus (HIV) human hyperimmune immunoglobulin in HIV type 1-infected children (Pediatric AIDS clinical trials group protocol 273). J Infect Dis. 2000 Feb;181(2):548-54. doi: 10.1086/315224.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety, tolerance, pharmacokinetics, and antiviral activity of human anti-HIV immune serum globulin ( HIVIG ) at three dosage levels in HIV-infected children.\n\nPassive antibody therapy has been used with limited success in treating advanced HIV disease in adults. HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic donors. It is hypothesized that HIVIG will decrease the viral burden of moderately advanced HIV-positive children.', 'detailedDescription': 'Passive antibody therapy has been used with limited success in treating advanced HIV disease in adults. HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic donors. It is hypothesized that HIVIG will decrease the viral burden of moderately advanced HIV-positive children.\n\nChildren are randomized to receive HIVIG every 4 weeks for 6 months at one of three dose levels, then are followed for 3 months after the final infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nConcurrent Medication:\n\nRequired:\n\n* PCP prophylaxis according to CDC guidelines.\n\nAllowed:\n\n* Varicella-zoster immunoglobulin.\n* Hepatitis B immunoglobulin.\n* Prophylactic therapies not involving immunoglobulin.\n\nPatients must have:\n\n* HIV infection.\n* CD4 count \\> 200 cells/mm3 (ages 2-5 years) or \\> 100 cells/mm3 (age \\> 5 years).\n* Antiretroviral therapy for at least 6 months, with no change in regimen for at least 3 months prior to study entry.\n* Plasma ICD p24 \\>= 70 pg/ml that is stable or increasing prior to study entry.\n* Life expectancy of at least 6 months.\n\nPrior Medication: Required:\n\n* Antiretroviral therapy for at least 6 months, with stable dose for at least 3 months.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Severe diarrhea, nephrotic syndrome, or other protein-losing state that requires large doses of IVIG.\n* Any other condition requiring dosing with IVIG (e.g., ITP, hypogammaglobulinemia).\n* Acute illness with temperature \\>= 100 F and/or with IV antibiotics.\n* Grade 3 or worse clinical toxicities.\n* Unable to tolerate IV infusions at a minimum rate of 0.02 ml/kg/min.\n* Concomitant participation in an experimental antiretroviral or HIV vaccine trial.\n\nConcurrent Medication:\n\nExcluded:\n\n* IVIG.\n* Chemotherapy for an active malignancy.\n* MMR or rubella vaccinations.\n* Intramuscular immunoglobulin.\n\nPatients with the following prior condition are excluded:\n\n* History of severe reaction to IVIG.\n\nPrior Medication:\n\nExcluded:\n\n* IVIG within the past 60 days.\n* Chemotherapy for an active malignancy within the past year.\n* MMR or rubella vaccinations within the past 6 months.\n* Intramuscular immunoglobulin within the past 60 days.\n\nOngoing drug or alcohol abuse.'}, 'identificationModule': {'nctId': 'NCT00000827', 'briefTitle': 'A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children', 'orgStudyIdInfo': {'id': 'ACTG 273'}, 'secondaryIdInfos': [{'id': '11249', 'type': 'REGISTRY', 'domain': 'DAIDS ES Registry Number'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Anti-HIV Immune Serum Globulin (Human)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB, Dept. of Ped., Div. of Infectious Diseases', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90801', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': "Long Beach Memorial Med. Ctr., Miller Children's Hosp.", 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Usc La Nichd Crs', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Pediatric AIDS CRS', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Univ. of Colorado Denver NICHD CRS', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Univ. of Connecticut Health Ctr., Dept. of Ped.', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '20060', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Howard Univ. Washington DC NICHD CRS', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Med. Ctr., ACTU", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ. of Florida Jacksonville NICHD CRS', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33161', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ. of Miami Ped. Perinatal HIV/AIDS CRS', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30306', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'BMC, Div. of Ped Infectious Diseases', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "HMS - Children's Hosp. Boston, Div. of Infectious Diseases", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Baystate Health, Baystate Med. Ctr.', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'WNE Maternal Pediatric Adolescent AIDS CRS', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': "Children's Hospital of Michigan NICHD CRS", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Paterson', 'state': 'New Jersey', 'country': 'United States', 'facility': "St. Joseph's Hosp. & Med. Ctr. of New Jersey", 'geoPoint': {'lat': 40.91677, 'lon': -74.17181}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': "Children's Hospital at Albany Medical Center, Dept. of Peds.", 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': "SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS", 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11021', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore-Long Island Jewish Health System, Dept. of Peds.', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia IMPAACT CRS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Incarnation Children's Ctr.", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10037', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Harlem Hosp. Ctr. NY NICHD CRS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Med. Ctr., Dept. of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Strong Memorial Hospital Rochester NY NICHD CRS', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Stony Brook NICHD CRS', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "The Children's Hosp. of Philadelphia IMPAACT CRS", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'St. Jude/UTHSC CRS', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Med. Ctr. Dallas", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hosp. CRS", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'UW School of Medicine - CHRMC', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'San Juan City Hosp. PR NICHD CRS', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'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': 'Stiehm ER', 'role': 'STUDY_CHAIR'}, {'name': 'Wara DW', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'North American Biologicals Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}