Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-25 @ 2:59 PM
Study NCT ID:
NCT00298350
Status:
COMPLETED
Last Update Posted:
2008-07-29
First Post:
2006-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.
Sponsor:
Organization:
Raw JSON
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Activity of elvitegravir, a once-daily integrase inhibitor, against resistant HIV Type 1: results of a phase 2, randomized, controlled, dose-ranging clinical trial. J Infect Dis. 2010 Mar 15;201(6):814-22. doi: 10.1086/650698.'}], 'seeAlsoLinks': [{'url': 'http://www.Gilead.com', 'label': 'Gilead Website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the non-inferiority of ritonavir-boosted GS-9137 relative to a ritonavir-boosted Comparator Protease Inhibitor when used as part of combination antiretroviral regimens in subjects who have failed, or are failing, protease inhibitor therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV RNA greater than or equal to 1000 c/mL.\n* Failed/Failing protease inhibitor based antiretroviral therapy.\n* Stable antiretroviral therapy for greater than or equal to 30 days prior to screening.\n* Negative Serum Pregnancy Test.\n* GFR by Cockcroft Gault greater than or equal to 80 mL/min.\n* AST \\& ALT less than or equal to 2.5x ULN.\n* Total Bilirubin less than or equal to 1.5 mg/dL.\n* Albumin greater than 3.5 mg/dL.\n* Prothrombin Time INR 1.0-1.4\n* Platelets greater than or equal to 50,000.\n* Hemoglobin greater than or equal to 8.0 mg/dL.\n* Absolute Neutrophil Count greater than or equal to 1000.\n\nExclusion Criteria:\n\n* New AIDS defining condition within 30 days of baseline.\n* Prior treatment with HIV-1 integrase inhibitor (except patients from 183-101).\n* Ascites or encephalopathy.\n* Breast Feeding.\n* Cancer Diagnosis (besides Kaposi Sarcoma or Basal Cell Carcinoma).'}, 'identificationModule': {'nctId': 'NCT00298350', 'briefTitle': 'Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'Phase 2 Study of the Treatment of Antiretroviral Treatment-Experienced Subjects Comparing Ritonavir-Boosted GS-9137 (GS-9137/r) vs. a Comparator Ritonavir-Boosted Protease Inhibitor (CPI/r) in Combination With Background ART.', 'orgStudyIdInfo': {'id': 'GS-US-183-0105'}}, 'armsInterventionsModule': {'interventions': [{'name': 'GS-9137 - A Novel HIV-1 Integrase Inhibitor', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72207', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '60813', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, 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