Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-01-04 @ 7:19 AM
Study NCT ID:
NCT00017992
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2001-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emtricitabine Given Once A Day With Other Anti-HIV Drugs in Children With HIV
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': 'D061466', 'term': 'Lopinavir'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D018119', 'term': 'Stavudine'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-03', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2001-06-23', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['HIV-1', 'Drug Administration Schedule', 'Stavudine', 'HIV Protease Inhibitors', 'Ritonavir', 'Reverse Transcriptase Inhibitors', 'Anti-HIV Agents', 'Pharmacokinetics', 'ABT 378', 'emtricitabine'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if emtricitabine is safe in children infected with HIV and to determine the best dose.', 'detailedDescription': 'Children are placed into 1 of 4 treatment groups based on age: Group 1, 3 months to 24 months; Group 2, 25 months to 6 years; Group 3, 7 years to 12 years; Group 4, 13 years to 17 years. They receive baseline evaluations. Antiretroviral-naive patients receive emtricitabine plus stavudine plus lopinavir/ritonavir. Antiretroviral-experienced patients replace lamivudine with emtricitabine. Patients return to the clinic for follow-up visits at Weeks 2 and 4 and then every 4 weeks until Week 48. Safety is evaluated using adverse events, which are reviewed at every clinic visit. Clinical laboratory data and full-profile pharmacokinetics of emtricitabine are evaluated at some visits. After the Week 48 study evaluations are completed, individual patients may continue to receive study medication (as provided by the sponsor) until commercially available, if certain criteria are met.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nChildren may be eligible for this study if they:\n\n* Are at least 3 months old and no older than 17 years of age. This is the age the child needs to be at the time they begin the study.\n* Are HIV positive.\n* Weigh more than 5.5 pounds. A newborn child must have reached at least 38 weeks of gestation.\n* Have or have not taken anti-HIV drugs. Those that have not must have a viral load between 5,000 and 500,000 copies/ml at screening. Those that have must have been taking anti-HIV drugs, including lamivudine, for at least 3 months and have a viral load of no more than 400 copies/ml at screening.\n* Have a CD4 count of more than 200 cells/mm3.\n* Have written consent from parent or guardian.\n* Are willing to use effective birth control during the study and for 1 month after the last dose of emtricitabine, if sexually active.\n\nExclusion Criteria\n\nChildren will not be eligible for this study if they:\n\n* Are pregnant or breast-feeding.\n* Cannot follow the visit or dosing schedule or are not available for 1 year.\n* Have taken experimental drugs or vaccines (except for emivirine and experimental forms of approved drugs) within 30 days of study start.\n* Have nerve damage in their arms or legs.\n* Have trouble eating or taking drugs.\n* Have serious diarrhea within 30 days before study entry.\n* Have had any serious illness within 30 days of study screening. Any treatment must have been finished 14 days before study entry.\n* Have had an AIDS-related (opportunistic) disease within 12 months of screening.\n* Are being treated for tuberculosis.\n* Have had pancreatitis.\n* Require certain drugs.'}, 'identificationModule': {'nctId': 'NCT00017992', 'briefTitle': 'Emtricitabine Given Once A Day With Other Anti-HIV Drugs in Children With HIV', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'An Open-Label Study of a Once Daily Dose of Emtricitabine in Combination With Other Antiretroviral Agents in HIV-Infected Pediatric Patients', 'orgStudyIdInfo': {'id': '298D'}, 'secondaryIdInfos': [{'id': 'FTC-203'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Lopinavir/Ritonavir', 'type': 'DRUG'}, {'name': 'Emtricitabine', 'type': 'DRUG'}, {'name': 'Stavudine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'USC School of Medicine / LA County Med Ctr', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Univ of Florida Health Science Ctr / Pediatrics', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '331016960', 'city': 'Miami', 'state': 'Florida', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Univ of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'New York Hosp / Cornell Med Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10025', 'city': 'New York', 'state': 'New York', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': "St Luke's - Roosevelt Hosp Ctr", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '117948111', 'city': 'Stony Brook', 'state': 'New York', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'State Univ of New York at Stony Brook', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Bronx Municipal Hosp Ctr/Jacobi Med Ctr', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '381052794', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': "Saint Jude Children's Research Hosp of Memphis", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'city': 'Buenos Aires', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Argentina', 'facility': 'Fundacion HUES', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Colonia Roma', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Mexico', 'facility': 'Instituto Mexicano de Investigacion Clinica', 'geoPoint': {'lat': 19.41819, 'lon': -99.16305}}, {'city': 'Panama City', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Panama', 'facility': 'Hospital del Nino', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'zip': '00936', 'city': 'San Juan', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Puerto Rico', 'facility': 'Univ of Puerto Rico / Med Science Campus', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'city': 'Diepkloof', 'status': 'RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Dr. Avy Violari', 'role': 'CONTACT', 'email': 'violari@mweb.co.za', 'phone': '011+27 11 989 9700'}], 'facility': 'Perinatal HIV Research UNIT', 'geoPoint': {'lat': -26.24358, 'lon': 27.9505}}, {'city': 'Gaunteng', 'status': 'RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Pauline Francesca Conradie', 'role': 'CONTACT', 'email': 'francesca_conradie@witshealth.co.za', 'phone': '011+ 27 11 717 2810'}], 'facility': 'Infectious Diseases Clinincal Trial Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Triangle Pharmaceuticals', 'class': 'INDUSTRY'}}}}