Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-07 @ 6:50 AM
Study NCT ID:
NCT00135395
Status:
COMPLETED
Last Update Posted:
2010-02-05
First Post:
2005-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase IIIb Study Comparing Two Boosted Protease Inhibitor-based HAART Regimens in HIV-infected Patients Experiencing Their First Virologic Failure While Receiving an NNRTI-containing HAART Regimen
Sponsor:
Organization:
Raw JSON
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LPV/RTV) in HIV-1 infected subjects who have experienced their first virologic failure while receiving a NNRTI-containing HAART regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients ≥ 18 years of age infected with HIV\n* Plasma HIV RNA ≥ 1000 copies/mL and CD4 cell count ≥ 50 cells/mm3\n* Currently receiving a NNRTI-containing HAART regimen or not currently receiving a NNRTI-containing HAART regimen and have not been treated with an alternative regimen since the documented virologic failure (with genotype performed within 2 weeks of the discontinuation of the failing regimen and the genotype report is available)\n* The failing NNRTI-containing regimen must be the patient's first virologic failure on treatment and contain a NNRTI and at least 2 NRTIs. The regimen must have been administered for at least 24 weeks and the patient must have documented virologic response to the regimen (HIV RNA \\< 400 c/mL)\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Reported virologic failure to two or more antiretroviral regimens\n* Active AIDS-defined opportunistic infection or disease\n* Proven or suspected acute hepatitis within 30 days prior to study entry"}, 'identificationModule': {'nctId': 'NCT00135395', 'briefTitle': 'A Phase IIIb Study Comparing Two Boosted Protease Inhibitor-based HAART Regimens in HIV-infected Patients Experiencing Their First Virologic Failure While Receiving an NNRTI-containing HAART Regimen', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase IIIb, Open -Label, Randomized Multi-center Study Comparing the Antiviral Efficacy, Safety, and Effect on Serum Lipids of Atazanavir/Ritonavir Versus Lopinavir/Ritonavir, in Combination With Two Nucleoside or Nucleotide Reverse Transcriptase Inhibitors (NRTIs) in HIV-1 Infected Subjects Experiencing Their First Virologic Failure While Receiving a NNRTI-containing HAART Regimen.', 'orgStudyIdInfo': {'id': 'AI424-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'interventionNames': ['Drug: Atazanavir+ritonavir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: Lopinavir+ritonavir']}], 'interventions': [{'name': 'Atazanavir+ritonavir', 'type': 'DRUG', 'otherNames': ['Reyataz'], 'description': 'Capsules, Oral, 300mg/100mg, once daily, 24 weeks.', 'armGroupLabels': ['A']}, {'name': 'Lopinavir+ritonavir', 'type': 'DRUG', 'description': 'Capsules, Oral, 800mg/200mg, twice daily, 24 weeks.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hobson City', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.62149, 'lon': -85.84413}}, {'city': 'Montgomery', 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