Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2025-12-27 @ 9:57 PM
Study NCT ID:
NCT00009061
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2001-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of GW433908/Ritonavir to Nelfinavir When Used With Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs
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': 'D019438', 'term': 'Ritonavir'}, {'id': 'C106538', 'term': 'abacavir'}, {'id': 'D019888', 'term': 'Nelfinavir'}, {'id': 'D019259', 'term': 'Lamivudine'}, {'id': 'C426859', 'term': 'fosamprenavir'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D016047', 'term': 'Zalcitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 624}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2000-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-03', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2001-01-23', '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', 'Ritonavir', 'Lamivudine', 'Nelfinavir', 'Reverse Transcriptase Inhibitors', 'Anti-HIV Agents', 'abacavir'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare virus response to GW433908/ritonavir (RTV) to viral response to nelfinavir (NFV) when used with abacavir (ABC)/lamivudine (3TC) in patients that have not taken antiretroviral (ART) drugs.', 'detailedDescription': 'Patients are randomized to 1 of 2 treatment arms. One arm is treated with GW433908/RTV plus ABC and 3TC. The other is treated with NFV plus ABC and 3TC. Each group is treated for 48 weeks. The following are compared in the 2 arms: 1) magnitude and durability of antiviral response; 2) safety, tolerance, and antiviral response after 24 and 48 weeks of therapy; 3) time to treatment failure; 4) immunologic response; 5) occurrence of events related to metabolic abnormalities; and 6) development of viral resistance in a subset of patients following treatment. Also studied are: 1) steady-state plasma drug trough concentrations; 2) demographic, virologic, immunologic, pharmacologic, and adherence factors that may be associated with treatment outcome; 3) patient adherence to the drug regimens; 4) study medication utilization; and 5) resource utilization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatients may be eligible for this study if they:\n\n* Are at least 13 years old (consent of parent or guardian needed if under 18).\n* Agree to use a proven barrier method of birth control (e.g., spermicide plus condom) during the study period (hormonal birth control will not be accepted), if able to have children.\n* Have received less than 4 weeks treatment with any nucleoside reverse transcriptase inhibitor (NRTI) and have never received any nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI). Mothers who have previously received 1 dose of the NNRTI nevirapine during pregnancy for prevention of mother-to-child HIV transmission are permitted to enter the study.\n* Have a viral load (amount of HIV in the blood) of 1,000 copies/ml or more.\n\nExclusion Criteria\n\nPatients will not be eligible for this study if they:\n\n* Abuse drugs or alcohol in a way that would interfere with study requirements. Patients who are stable on methadone will be considered for the study.\n* Have an active/acute CDC Category C event.\n* Are unable to absorb or take medicines by mouth.\n* Are pregnant or breast-feeding.\n* Have a serious medical condition (such as diabetes, heart problem, hepatitis) that might affect the safety of the patient.\n* Have had pancreatitis or hepatitis within the last 6 months.\n* Have been treated with radiation or chemotherapy within 28 days before the study drug will be taken, or will have the need for these during the study.\n* Have taken drugs that affect the immune system (such as corticosteroids, interleukins, interferons) or that have anti-HIV activity (such as hydroxyurea or foscarnet) within 28 days before the study drug will be taken.\n* Have received an HIV vaccine within 3 months before the study drug will be taken.\n* Have received certain other drugs within 28 days before the study drug will be taken, or think that they will be needed during the study.\n* Have received experimental treatments.\n* Have allergies which might interfere with the study, in the opinion of the doctor.'}, 'identificationModule': {'nctId': 'NCT00009061', 'briefTitle': 'Comparison of GW433908/Ritonavir to Nelfinavir When Used With Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Randomized, Open-Label, Two Arm Trial to Compare the Safety and Antiviral Efficacy of GW433908/Ritonavir QD to Nelfinavir BID When Used in Combination With Abacavir and Lamivudine for 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Subjects', 'orgStudyIdInfo': {'id': '316B'}, 'secondaryIdInfos': [{'id': 'APV30002'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Ritonavir', 'type': 'DRUG'}, {'name': 'Abacavir sulfate', 'type': 'DRUG'}, {'name': 'Nelfinavir mesylate', 'type': 'DRUG'}, {'name': 'Lamivudine', 'type': 'DRUG'}, {'name': 'GW433908', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Ctr for Special Immunology', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'AIDS Healthcare Foundation', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90028', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'LAGLC', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Hospital', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Park Ctr for Health / Keith Vrhel', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90069', 'city': 'West Hollywood', 'state': 'California', 'country': 'United States', 'facility': 'AIDS Research Alliance', 'geoPoint': {'lat': 34.09001, 'lon': -118.36174}}, {'zip': '200091104', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Dupont Circle Physicians Group', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32701', 'city': 'Altamonte Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'Infectious Disease Consultants', 'geoPoint': {'lat': 28.66111, 'lon': -81.36562}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'CRI of South Florida', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Therafirst Med Ctr', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Gary Richmond MD', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ of Miami Dept of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33142', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Specialty Med Care Ctrs of South Florida Inc', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Infectious Diseases Associates', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33710', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Jeffrey Levenson', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Infectious Disease Research Inst', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'AIDS Research Consortium of Atlanta', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Med College of Georgia', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30013', 'city': 'Conyers', 'state': 'Georgia', 'country': 'United States', 'facility': 'SMO USA', 'geoPoint': {'lat': 33.66761, 'lon': -84.01769}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Univ Med School', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hosp", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02745', 'city': 'New Bedford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Hawthorne Med Associates / PAACA', 'geoPoint': {'lat': 41.63526, 'lon': -70.92701}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Abbott-Northwestern Hosp / Clinic 42', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63139', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Southampton Healthcare Inc', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07018', 'city': 'East Orange', 'state': 'New Jersey', 'country': 'United States', 'facility': 'VAMC New Jersey Healthcare System', 'geoPoint': {'lat': 40.76732, 'lon': -74.20487}}, {'zip': '071032842', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'North Jersey Community Research Initiative', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY / Erie County Med Ctr at Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore Univ Hosp', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'St Lukes - Roosevelt Hosp Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10468', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Bronx Veterans Affairs Med Ctr', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '452670405', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Univ of Cincinnati / Holmes Hosp', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '170330850', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Milton S Hershey Med Ctr', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19102', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hahnemann Univ Hosp', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29206', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Burnside Clinic', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Methodist Healthcare', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Nicholas Bellos', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Joseph C Gathe', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glaxo Wellcome', 'class': 'INDUSTRY'}}}}