Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-01-06 @ 6:26 PM
Study NCT ID:
NCT00120393
Status:
COMPLETED
Last Update Posted:
2010-02-05
First Post:
2005-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of HIV Patients With Undetectable Viral Load and Abnormal Lipids Switching to Atazanavir/Ritonavir
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': 'D000069446', 'term': 'Atazanavir Sulfate'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'dispFirstSubmitDate': '2010-02-03', 'completionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-03', 'studyFirstSubmitDate': '2005-07-12', 'dispFirstSubmitQcDate': '2010-02-03', 'studyFirstSubmitQcDate': '2005-07-15', 'dispFirstPostDateStruct': {'date': '2010-02-05', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2010-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the Week 12 percent change from baseline in fasting non-HDL cholesterol between subjects who are switched to an ATV/RTV-containing regimen and those who continue on a LPV/RTV based regimen.'}], 'secondaryOutcomes': [{'measure': 'Mean percent change in fasting non-HDL cholesterol at Weeks 24 and 48.'}, {'measure': 'Mean change in cholesterol measures at Weeks 12, 24 and 48.'}, {'measure': 'Mean percent changes from baseline in fasting glucose and insulin at Weeks 12, 24 and 48.'}, {'measure': 'The proportion of subjects receiving lipid lowering therapy at Weeks 24 and 48.'}, {'measure': 'The proportion of subjects with LDL cholesterol less than 130mg/dL at Weeks 12, 24 and 48.'}, {'measure': 'The proportion of subjects with non-HDL cholesterol less than 160mg/dL at Weeks 12, 24 and 48.'}, {'measure': 'The frequency and severity of all clinical and laboratory AEs and discontinue for AEs.'}]}, 'conditionsModule': {'keywords': ['Treatment Experienced'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'Patients with HIV who are virologically suppressed on a lopinavir/ritonavir combination highly active antiretroviral therapy (HAART) regimen but with elevated non-HDL cholesterol are randomized to remain on lopinavir/ritonavir or change to atazanavir/ritonavir in combination with current nucleoside reverse transcriptase inhibitors (NRTIs).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV positive\n* LPV/RTV-based HAART for at least 6 months\n* HIV-1 RNA less than 50c/mL (confirmed)\n* Non-HDL higher than 160 mg/dL\n* CD4 of at least 50 cells/mL\n\nExclusion Criteria:\n\n* Use of lipid-lowering agents'}, 'identificationModule': {'nctId': 'NCT00120393', 'briefTitle': 'Study of HIV Patients With Undetectable Viral Load and Abnormal Lipids Switching to Atazanavir/Ritonavir', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase IIIB, Open-label, Randomized, Multi-center Study Evaluating the Effect on Serum Lipids Following a Switch to ATV/r in HIV-1 Infected Subjects Who Have Achieved Virologic Suppression on a LPV/r Based Regimen.', 'orgStudyIdInfo': {'id': 'AI424-100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'G1', 'interventionNames': ['Drug: atazanavir/ritonavir +2 NRTIs (immediate Switch Group)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'G2', 'interventionNames': ['Drug: LPV/r +2 NRTIs (Delayed/optional Switch Group)']}], 'interventions': [{'name': 'atazanavir/ritonavir +2 NRTIs (immediate Switch Group)', 'type': 'DRUG', 'otherNames': ['Reyataz'], 'description': 'Capsules, Oral, ATV 300mg/RTV 100mg + 2 NRTIs, QD, 48 weeks.', 'armGroupLabels': ['G1']}, {'name': 'LPV/r +2 NRTIs (Delayed/optional Switch Group)', 'type': 'DRUG', 'description': 'Capsules, Oral, LPV 400mg/RTV 100mg +2 NRTIs, BID, 24 weeks then option to switch to ATV arm or stay until 48 weeks.', 'armGroupLabels': ['G2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'Bristol-Myers Squibb'}}}}