Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:48 AM
Study NCT ID:
NCT00001118
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of a New Anti-HIV Drug, T-20, in HIV-Infected Children
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': 'D000077560', 'term': 'Enfuvirtide'}], 'ancestors': [{'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D015700', 'term': 'HIV Envelope Protein gp41'}, {'id': 'D014760', 'term': 'Viral Fusion Proteins'}, {'id': 'D050576', 'term': 'Membrane Fusion Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D015488', 'term': 'HIV Antigens'}, {'id': 'D000956', 'term': 'Antigens, Viral'}, {'id': 'D014764', 'term': 'Viral Proteins'}, {'id': 'D054299', 'term': 'env Gene Products, Human Immunodeficiency Virus'}, {'id': 'D015686', 'term': 'Gene Products, env'}, {'id': 'D012191', 'term': 'Retroviridae Proteins'}, {'id': 'D054298', 'term': 'Human Immunodeficiency Virus Proteins'}, {'id': 'D014759', 'term': 'Viral Envelope Proteins'}, {'id': 'D015678', 'term': 'Viral Structural Proteins'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2002-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-28', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Injections, Intravenous', 'Injections, Subcutaneous', 'Drug Therapy, Combination', 'HIV Protease Inhibitors', 'Membrane Fusion', 'Reverse Transcriptase Inhibitors', 'Anti-HIV Agents', 'Viral Load', 'peptide T20'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Kosel B, Church J, Cunningham C, Sista P, Aweeka F. Pharmacokinetics (PK) of selected doses of T-20, a fusion inhibitor, in HIV-1-infected children. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 726)'}, {'pmid': '12237598', 'type': 'RESULT', 'citation': 'Church JA, Cunningham C, Hughes M, Palumbo P, Mofenson LM, Delora P, Smith E, Wiznia A, Purdue L, Hawkins E, Sista P; PACTG P1005 Study Team. Pediatric AIDS Clinical Trials Group. Safety and antiretroviral activity of chronic subcutaneous administration of T-20 in human immunodeficiency virus 1-infected children. Pediatr Infect Dis J. 2002 Jul;21(7):653-9. doi: 10.1097/00006454-200207000-00010.'}, {'pmid': '14663459', 'type': 'RESULT', 'citation': 'Soy D, Aweeka FT, Church JA, Cunningham CK, Palumbo P, Kosel BW, Sheiner LB; Pediatric AIDS Clinical Trial Group (PACTG) Study P1005 Investigators. Population pharmacokinetics of enfuvirtide in pediatric patients with human immunodeficiency virus: searching for exposure-response relationships. Clin Pharmacol Ther. 2003 Dec;74(6):569-80. doi: 10.1016/j.clpt.2003.09.002.'}, {'pmid': '15295220', 'type': 'RESULT', 'citation': 'Church JA, Hughes M, Chen J, Palumbo P, Mofenson LM, Delora P, Smith E, Wiznia A, Hawkins E, Sista P, Cunningham CK; Pediatric AIDS Clinical Trials Group P1005 Study Team. Long term tolerability and safety of enfuvirtide for human immunodeficiency virus 1-infected children. Pediatr Infect Dis J. 2004 Aug;23(8):713-8. doi: 10.1097/01.inf.0000133045.45316.6a.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the best dose of T-20, a new anti-HIV drug, to treat HIV-infected children.\n\nT-20, unlike other anti-HIV medications, lessens the ability of HIV to infect certain cells (T cells) in the body. Doctors hope to better treat HIV by adding T-20 to anti-HIV drug combinations that include 1 or 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) and/or a protease inhibitor (PI).', 'detailedDescription': 'T-20 is the first drug to be developed which specifically inhibits the function of the gp41 transmembrane glycoprotein. By inhibiting the essential protein-protein surface interaction, T-20 is able to block the process of virus-to-host cell membrane fusion. Combination antiretroviral regimens (reverse transcriptase inhibitors plus PIs) have benefited many HIV patients, but heavily pretreated patients often develop multi-drug resistance via multiple gene mutations. A pharmacologic agent, such as T-20, that is effective at an alternative point in the virus replication cycle will make a valuable addition to the treatment of HIV infection.\n\nThis Phase I/II open-label, dose-escalating, randomized study is divided into 2 parts. Patients may participate in Part A and/or Part B. Part A (single dosing): 12 patients are sequentially assigned to receive 1 of 3 doses of T-20 given once on Day 0 by SC injection into the abdomen, deltoid area, or anterior aspect of the thigh and once on Day 1 by IV infusion. Provided safety criteria are met, patients who complete Part A, or new enrollees who did not participate in Part A, enroll in Part B. Doses for Part B are determined by pharmacokinetic data obtained in Part A. \\[AS PER AMENDMENT 4/20/00: Current data has now projected a pediatric dose. Each child will move to chronic dosing in Part B provided the child has no Grade 3 or higher toxicity to study drug through Day 7 in Part A.\\] Part B (multiple dosing): Patients are randomly assigned to 1 of 3 dose cohorts to receive 24 weeks \\[AS PER AMENDMENT 12/7/00: 48 weeks\\] of treatment (optional extension to 48 weeks \\[AS PER AMENDMENT 12/7/00: 96 weeks\\]) with bid SC injections of T-20. Cohort 1 receives the dose identified in Part A (Dose 1) as the lowest dose that is well tolerated and that achieves the target trough plasma concentration. Cohort 2 receives the next higher dose from Dose 1 (Dose 2). Cohort 3 receives either Dose 1 or Dose 2, depending on the tolerability and antiviral activity of each dose. \\[AS PER AMENDMENT 4/20/00: Cohort 1 receives 30 mg/m2 SC bid (Dose 1); Cohort 2 receives 60 mg/m2 SC bid (Dose 2); and Cohort 3 receives Dose 1 or 2 SC bid.\\] On Day 7 of T-20 dosing, children begin a new antiretroviral therapy regimen chosen by the site investigator based on study parameters. (Abacavir and amprenavir are not allowed for this regimen.) \\[AS PER AMENDMENT 1/6/00: Abacavir and amprenavir are now allowed.\\] The first injection will be given in the clinic and a parent/guardian will be trained to give successive injections. \\[AS PER AMENDMENT 4/20/00: The 2 doses given prior to obtaining trough levels on Days 1 and 7 must be directly observed by medical personnel.\\] Patients undergo clinical and laboratory evaluations to monitor viral load, HIV-related symptoms, and pharmacokinetics at time points throughout the study. Patients participating in Part A are evaluated at the clinic on Days 0, 1, and 7. Patients participating in Part B are evaluated at the clinic 6 times during the first 3 weeks and then every 4 weeks through Week 24. \\[AS PER AMENDMENT 12/7/00: Patients participating in Part B are evaluated at the clinic 6 times during the first 3 weeks, every 4 weeks through Week 24, and then every 8 weeks through Week 48.\\]'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nChildren may be eligible for this study if they:\n\n* Are 3 to 12 years old (consent of parent or guardian required).\n* Are HIV-positive.\n* Are receiving combination anti-HIV therapy. He/she must have been taking this combination for at least 16 weeks, and it must include either 2 NRTIs alone or 2 NRTIs plus either an NNRTI or a PI. (This study has been changed. This no longer has to be a child's first anti-HIV drug combination.)\n* Have a viral load greater than 10,000 copies/ml while taking this anti-HIV drug combination.\n* Have never received treatment with a PI or an NNRTI. (One or two doses are allowed.)\n* Have never taken at least 1 NRTI.\n\nExclusion Criteria\n\nChildren will not be eligible for this study if they:\n\n* Are receiving treatment for an opportunistic (AIDS-related) or serious bacterial infection at the time of study entry.\n* Are receiving chemotherapy for cancer.\n* Have certain serious diseases (other than HIV) or conditions.\n* Have received or are currently receiving certain medications.\n* Are pregnant."}, 'identificationModule': {'nctId': 'NCT00001118', 'briefTitle': 'Study of a New Anti-HIV Drug, T-20, in HIV-Infected Children', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Phase I/II Study of T-20, a Fusion Inhibitor, in HIV-1 Infected Children', 'orgStudyIdInfo': {'id': 'P1005'}, 'secondaryIdInfos': [{'id': '11642', 'type': 'REGISTRY', 'domain': 'DAIDS ES'}, {'id': 'ACTG P1005'}, {'id': 'PACTG P1005'}, {'id': 'T20-204'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Enfuvirtide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '920930672', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Med Ctr / Pediatrics / Clinical Sciences', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90801', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Long Beach Memorial (Pediatric)', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '900276016', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hosp of Los Angeles/UCLA Med Ctr", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '941430105', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF / Moffitt Hosp - Pediatric', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'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': '33161', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ of Miami (Pediatric)', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'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': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston City Hosp / Pediatrics', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Baystate Med Ctr of Springfield', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '016550001', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Univ of Massachusetts Med School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': "Children's Hosp of Michigan", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'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': '11021', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore Univ Hosp', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Bellevue Hosp / New York Univ Med Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Metropolitan Hosp 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': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Health Sciences Ctr at Syracuse / Pediatrics', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '10457', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Bronx Lebanon Hosp Ctr', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Bronx Municipal Hosp Ctr/Jacobi Med Ctr', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '277103499', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Univ Med Ctr', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '294253312', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Med Univ of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '009367344', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'San Juan City Hosp', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Joseph Church', 'role': 'STUDY_CHAIR'}, {'name': 'Coleen Cunningham', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}