Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT00135369
Status:
COMPLETED
Last Update Posted:
2011-04-25
First Post:
2005-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Switching HIV-1 Infected Subjects From a Highly Active Anti-Retroviral Treatment (HAART) Regimen Dosed Twice Daily or More Frequently to a Once-Daily Regimen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], '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'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019259', 'term': 'Lamivudine'}, {'id': 'C098320', 'term': 'efavirenz'}], 'ancestors': [{'id': 'D016047', 'term': 'Zalcitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, 'statusVerifiedDate': '2011-04', 'dispFirstSubmitDate': '2010-01-28', 'completionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-08', 'studyFirstSubmitDate': '2005-08-25', 'dispFirstSubmitQcDate': '2010-01-28', 'studyFirstSubmitQcDate': '2005-08-25', 'dispFirstPostDateStruct': {'date': '2010-02-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy at week 48'}], 'secondaryOutcomes': [{'measure': 'Safety, tolerability and efficacy at weeks (wks) 24 and 48; Effect on lipids at wks 24 and 48; Adherence, quality of life changes, treatment satisfaction and preference at wks 12, 24 and 48'}]}, 'conditionsModule': {'keywords': ['HIV-AIDS'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a standard-of-care regimen dosed twice-daily or more frequently to a simpler once-daily (QD) regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels \\<50 copies/mL after switching to a QD regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented HIV infection\n* 18 years of age or older and weigh at least 40 kg\n* Two plasma HIV RNA levels below the limit of quantification (one at least 90 days prior to the screening visit and one within 30 days of the patients baseline visit)\n* Currently receiving a standard-of-care HAART regimen with at least one agent being dosed twice-daily or more frequently\n\nExclusion Criteria:\n\n* Pregnancy, breastfeeding or plans to become pregnant during the study period\n* Any prior documented virologic failure to one or more HAART regimens\n* Active AIDS-defining opportunistic infection or disease\n* Proven or suspected acute hepatitis within 30 days prior to study entry'}, 'identificationModule': {'nctId': 'NCT00135369', 'briefTitle': 'Switching HIV-1 Infected Subjects From a Highly Active Anti-Retroviral Treatment (HAART) Regimen Dosed Twice Daily or More Frequently to a Once-Daily Regimen', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 3 Study Switching HIV-1 Infected Subjects With an Undetectable Viral Load From a HAART Regimen Dosed Twice Daily or More Frequently to a Once-Daily HAART Regimen', 'orgStudyIdInfo': {'id': 'AI455-135'}}, 'armsInterventionsModule': {'interventions': [{'name': 'stavudine extended-release, lamivudine, efavirenz', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hobson City', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.62149, 'lon': -85.84413}}, {'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'San Mateo', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.56299, 'lon': -122.32553}}, {'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Norwalk', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.1176, 'lon': -73.4079}}, {'city': 'Stratford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.18454, 'lon': -73.13317}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Berkley', 'state': 'Michigan', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 42.50309, 'lon': -83.18354}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'city': 'Jersey City', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.72816, 'lon': -74.07764}}, {'city': 'Neptune City', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.20011, 'lon': -74.02792}}, {'city': 'Somers Point', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.31762, 'lon': -74.5946}}, {'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'city': 'Huntersville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'city': 'Washington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.54655, 'lon': -77.05217}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Reading', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.33565, 'lon': -75.92687}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Annandale', 'state': 'Virginia', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.83039, 'lon': -77.19637}}, {'city': 'Hampton', 'state': 'Virginia', 'country': 'United States', 'facility': 'Local Institution', 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