Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-26 @ 1:36 AM
Study NCT ID:
NCT00144833
Status:
TERMINATED
Last Update Posted:
2007-11-12
First Post:
2005-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open Label Study of 908/RTV in Combination With Other PIs for the Treatment of Multi PI-Experienced HIV Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C426859', 'term': 'fosamprenavir'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'C494814', 'term': 'BID protein, human'}, {'id': 'D061466', 'term': 'Lopinavir'}], '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': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'whyStopped': 'Incomplete data', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'lastUpdateSubmitDate': '2007-11-09', 'studyFirstSubmitDate': '2005-09-01', 'studyFirstSubmitQcDate': '2005-09-01', 'lastUpdatePostDateStruct': {'date': '2007-11-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The average area under the curve minus baseline [AAUCMB] in plasma HIV-1 RNA at 24 Weeks when each are administered in combination with an optimised background therapy, in a multiple PI-experienced population experiencing virological failure.', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Efficacy (AAUCMB) at 48 weeks, safety, tolerability(incidence and nature of AEs and laboratory abnormalities) at week 24 and 48, CD4 change from baseline at week 24 and 48, and the steady-state plasma APV and LPV through concentrations.', 'timeFrame': '48 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Protease inhibitors-experienced HIV-1 infected patients', 'Highly-resistant HIV-1', 'Dual boosted Pis', 'fosamprenavir', 'lopinavir'], 'conditions': ['HIV-1']}, 'descriptionModule': {'briefSummary': 'For HIV-infected individuals with highly resistant viruses, higher drug levels may be required to block the virus. This study investigates that concept by comparing the efficacy of standard fosamprenavir/ritonavir to an increased dose of boosted fosamprenavir and to a combination of fosamprenavir (increased dose)/lopinavir/ritonavir.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Multiple protease-inhibitors experienced HIV-1 infected individuals experiencing virological failure and who's virus is not fully resistant to boosted fosamprenavir and boosted lopinavir based on genotypic resistance tests.\n\nExclusion criteria:\n\n* No full resistance to FPV/r or LPV/r\n* Planned use of NNRTIs as part of the study salvage regimen\n* Application of additional exclusion criteria as determined by physician."}, 'identificationModule': {'nctId': 'NCT00144833', 'briefTitle': 'Open Label Study of 908/RTV in Combination With Other PIs for the Treatment of Multi PI-Experienced HIV Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Phase III, Randomized, Controlled, Open-Label, Multicentre, Three Arm Study to Compare the Efficacy and Safety of a Dual-Boosted HIV-1 Protease Inhibitor Regimen of Fosamprenavir/Lopinavir/Ritonavir 1400mg/533mg/133mg Twice Daily and an Increased Dosage Regimen of FPV/RTV 1400mg/100mg BID Versus the Standard Dosage Regimen of FPV/RTV 700mg/100mg BID for 24 Weeks in Multiple-PI Experienced, HIV-Infected Adults Experiencing Virological Failure', 'orgStudyIdInfo': {'id': 'APV102002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'fosamprenavir/ritonavir (700mg/100mg BID)', 'type': 'DRUG'}, {'name': 'fosamprenavir/ritonavir (1400mg/100mg BID)', 'type': 'DRUG'}, {'name': 'fosamprenavir/lopinavir/ritonavir (1400mg/533mg/100mg BID)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2010', 'city': 'Darlinghurst', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '3053', 'city': 'Carlton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': -37.8, 'lon': 144.96667}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'V6Z 2C7', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K1N 6N5', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M4T 3A7', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5B 1L6', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2L 5B1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G2', 'city': 'Saint-Foy', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Clinical Trials Call Center'}, {'zip': '77400', 'city': 'Lagny-sur-Marne', 'country': 'France', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 48.86667, 'lon': 2.71667}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75970', 'city': 'Paris', 'country': 'France', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '93009', 'city': 'Paris', 'country': 'France', 'facility': 'GSK Clinical Trials Call Centre', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '93205', 'city': 'Saint-Denis', 'country': 'France', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '83000', 'city': 'Toulon', 'country': 'France', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'zip': '54511', 'city': 'Vanouvre Les Nancy', 'country': 'France', 'facility': 'GSK Clinical Trials Call Center'}, {'zip': '20095', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '10676', 'city': 'Athens', 'country': 'Greece', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '11526', 'city': 'Athens', 'country': 'Greece', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '18536', 'city': 'Piraeus', 'country': 'Greece', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 37.94203, 'lon': 23.64619}}, {'zip': '16128', 'city': 'Liguria', 'country': 'Italy', 'facility': 'GSK Clinical Trials Call Center'}, {'zip': '27100', 'city': 'Lombardia', 'country': 'Italy', 'facility': 'GSK Clinical Trials Call Center'}, {'zip': '44100', 'city': 'Romagna', 'country': 'Italy', 'facility': 'GSK Clinical Trials Call Center'}, {'zip': '00 168', 'city': 'Rome', 'country': 'Italy', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '10149', 'city': 'Torino', 'country': 'Italy', 'facility': 'GSK Clinical Trials Call Centre', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '50126', 'city': 'Toscana', 'country': 'Italy', 'facility': 'GSK Clinical Trials Call Center'}, {'zip': '50139', 'city': 'Toscana', 'country': 'Italy', 'facility': 'GSK Clinical Trials Call Center'}, {'zip': '35128', 'city': 'Veneto', 'country': 'Italy', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 45.43816, 'lon': 10.86135}}, {'zip': '8025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '11407', 'city': 'Jerez de la Frontera', 'country': 'Spain', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 36.68645, 'lon': -6.13606}}, {'zip': '28029', 'city': 'Madrid', 'country': 'Spain', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'B29 JD6', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'GSK Clinical Trials call Center', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BN2 3EW', 'city': 'Brighton', 'country': 'United Kingdom', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'zip': 'EC1A 7BE', 'city': 'London', 'country': 'United Kingdom', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NW3 2QG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'GSK Clinical Trials, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}}}}