Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-02-21 @ 10:34 AM
Study NCT ID:
NCT00002193
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of Giving Two Nucleoside Reverse Transcriptase Inhibitors Alone or in Combination With 141W94 to HIV-Infected Children Who Have Never Received Protease Inhibitors
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': 'C095108', 'term': 'amprenavir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1999-06', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['HIV-1', 'Drug Therapy, Combination', 'HIV Protease Inhibitors', 'RNA, Viral', 'VX 478', 'Reverse Transcriptase Inhibitors', 'Anti-HIV Agents', 'Viral Load'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if it is safe and effective to add a new protease inhibitor (PI), 141W94, to an anti-HIV regimen that includes 2 nucleoside reverse transcriptase inhibitors (NRTIs).', 'detailedDescription': 'In this double-blind, placebo-controlled, pediatric study, 210 patients are randomized to receive 2 NRTIs plus either 141W94 or placebo. Enrollment of patients is sequential: patients 13 to 18 years of age are enrolled first, followed by children \\< 13 when the appropriate pediatric dose has been determined. Patients who are unable to swallow capsules will be accrued when a liquid formulation becomes available.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nYour child may be eligible for this study if he/she:\n\n* Is 6 months - 18 years of age.\n* Is HIV-positive.\n* Has a viral load (level of HIV in the body) greater than 10,000 copies/ml.\n* Is able to take medications by mouth.\n* Has consent of parent or legal guardian if under 18.\n* Has a negative pregnancy test within 7 days of study entry.\n* Agrees to practice abstinence or use effective methods of birth control for 1 month before and throughout the study.\n\nExclusion Criteria\n\nYour child will not be eligible for this study if he/she:\n\n* Has a serious illness, including any life-threatening infection or other chronic serious medical condition.\n* Has an opportunistic (AIDS-related) infection or a serious bacterial infection.\n* Is allergic to NRTIs.\n* Is breast-feeding.\n* Is unlikely to complete the study.\n* Has received certain medications.\n* Has received radiation therapy within the past 4 months, or will need to receive it during the study.'}, 'identificationModule': {'nctId': 'NCT00002193', 'briefTitle': 'Safety and Effectiveness of Giving Two Nucleoside Reverse Transcriptase Inhibitors Alone or in Combination With 141W94 to HIV-Infected Children Who Have Never Received Protease Inhibitors', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Safety and Efficacy of 141W94 Plus Current Nucleoside Therapy Versus Current Nucleoside Therapy Alone in Protease-Naive, HIV-Infected Children', 'orgStudyIdInfo': {'id': '264C'}, 'secondaryIdInfos': [{'id': 'PROA3004'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Amprenavir', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33301', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': "Children's Diagnostic Treatment Ctr", 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "Saint Jude Children's Hosp / Dept of Infect Diseases", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glaxo Wellcome', 'class': 'INDUSTRY'}}}}