Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 11:07 PM
Study NCT ID:
NCT00028067
Status:
TERMINATED
Last Update Posted:
2011-05-04
First Post:
2001-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparison of Atazanavir and Nelfinavir, Each in Combination With 2 NRTIs, in Patients Who Have Failed Treatments Without a Protease Inhibitor
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'}, {'id': 'D019888', 'term': 'Nelfinavir'}], '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'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 500}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-08'}, 'statusVerifiedDate': '2011-04', 'dispFirstSubmitDate': '2011-04-13', 'completionDateStruct': {'date': '2002-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-28', 'studyFirstSubmitDate': '2001-12-10', 'dispFirstSubmitQcDate': '2011-04-13', 'studyFirstSubmitQcDate': '2001-12-10', 'dispFirstPostDateStruct': {'date': '2011-04-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-04', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Drug Therapy, Combination', 'HIV Protease Inhibitors', 'RNA, Viral', 'Reverse Transcriptase Inhibitors', 'Viral Load', 'BMS 232632'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the atazanavir and nelfinavir (NFV) treatments in their ability to reduce viral load.', 'detailedDescription': 'In this double-blind, double-placebo, randomized, 2-arm study, atazanavir and NFV each are given in combination with 2 open-label nucleoside reverse transcriptase inhibitors (NRTIs) over 48 weeks. Patients assigned to atazanavir will receive placebo capsules which are identical in size and appearance to NFV. Patients assigned to NFV will receive placebo capsules which are identical in size and appearance to atazanavir. HIV levels are monitored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatients may be eligible for this study if they:\n\n* Have a viral load of 1000 or more copies/ml within 3 weeks before randomization. Have a CD4 cell count of 50 or more cells/mm3 within 3 weeks prior to randomization.\n* Are at least 16 years old (or the minimum age by local requirements).\n* Have had more than 16 weeks of therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI) and/or nucleoside reverse transcriptase inhibitor (NRTI).\n* Use effective barrier method of contraception.\n* Give written informed consent.\n* Are available for follow-up for at least 52 weeks.\n\nExclusion Criteria\n\nPatients may not be eligible for this study if they:\n\n* Have used a protease inhibitor (PI) treatment for more than 7 days or within 30 days prior to screening.\n* Have a newly-diagnosed HIV-related infection or any medical condition requiring relatively short but intense therapy at the time of enrollment.\n* Have hepatitis in the 30 days before the study. Patients with long-term hepatitis are eligible if their liver function meets certain requirements.\n* Are unable to demonstrate responsiveness to a provided NRTI.\n* Have had previous or expect a need for therapy with agents that may cause damage to nerve tissue, the pancreas, the liver, bone marrow, or cells within 3 months of study start.\n* Use too much alcohol or drugs to be able to follow the study therapy; or if they use enough to increase the risk of developing pancreatitis or chemical hepatitis.\n* Have severe diarrhea within 30 days prior to study entry.\n* Are pregnant or breast-feeding.\n* Have a history of hemophilia.\n* Have history or signs of bilateral peripheral neuropathy.\n* Have cardiomyopathy.\n* Have certain heart problems.\n* Cannot tolerate oral medication.\n* Have any other problems that would interfere with the study.'}, 'identificationModule': {'nctId': 'NCT00028067', 'briefTitle': 'A Comparison of Atazanavir and Nelfinavir, Each in Combination With 2 NRTIs, in Patients Who Have Failed Treatments Without a Protease Inhibitor', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase III Study Comparing the Antiviral Efficacy and Safety of Atazanavir With Nelfinavir: Each in Combination With Dual Nucleoside Therapy in HIV-Infected Subjects Who Have Failed a Regimen Not Containing a Protease Inhibitor', 'orgStudyIdInfo': {'id': '302F'}, 'secondaryIdInfos': [{'id': 'AI424-037'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Atazanavir', 'type': 'DRUG'}, {'name': 'Nelfinavir mesylate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Health for Life Clinic', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'East Bay AIDS Ctr', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Ctr for Special Immunology', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Tower Infectious Diseases', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Hospital', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94114', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'HIV Institute / Davies Med Ctr', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Foundation Hospital', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '32701', 'city': 'Altamonte Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'IDC Research Initiative', 'geoPoint': {'lat': 28.66111, 'lon': -81.36562}}, {'zip': '33462', 'city': 'Atlantis', 'state': 'Florida', 'country': 'United States', 'facility': 'Larry Bush', 'geoPoint': {'lat': 26.5909, 'lon': -80.10088}}, {'zip': '34205', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Bach and Godofsky', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33311', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'North Broward Hosp District / HIV Clinical Research', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Gary Richmond MD', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Infectious Diseases Associates', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Daniel Seekins', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Infectious Disease Research Inst', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Philip Brachman', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Med College of Georgia', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cook County Gen Hosp / Division of Infect Diseases', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Division of Inf Diseases/ Indiana Univ Hosp', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane Univ School of Medicine', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Med Ctr', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02445', 'city': 'Brookline', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Community Research Initiative of New England', 'geoPoint': {'lat': 42.33176, 'lon': -71.12116}}, {'zip': '01107', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'CRI - Springfield', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hosp', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48089', 'city': 'Warren', 'state': 'Michigan', 'country': 'United States', 'facility': 'Infectious Disease Clinic', 'geoPoint': {'lat': 42.49044, 'lon': -83.01304}}, {'zip': '63108', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington Univ School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08244', 'city': 'Somers Point', 'state': 'New Jersey', 'country': 'United States', 'facility': 'South Jersey Infectious Diseases Inc', 'geoPoint': {'lat': 39.31762, 'lon': -74.5946}}, {'zip': '10018', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Community Research Initiative on AIDS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Saint Luke's - Roosevelt Hosp Ctr", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Med Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein College of Medicine', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '28232', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Med Ctr', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28602', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Piedmont Infectious Disease Consultants', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Jemsek Clinic', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Univ School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44304', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Summa Health System', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '74114', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Associates in Med and Mental Health', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '97209', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Research & Education Group', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19102', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hahnemann Univ Hosp', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29414', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Ludwig Lettau Private Practice', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29203', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Univ of South Carolina School of Medicine', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '75208', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'North Texas Center for AIDS & Clinical Research', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ of Texas Southwestern Med Ctr', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Joseph Gathe', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ TX Health Science Ctr', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23666', 'city': 'Hampton', 'state': 'Virginia', 'country': 'United States', 'facility': 'Hampton Roads Med Specialists', 'geoPoint': {'lat': 37.02987, 'lon': -76.34522}}, {'zip': '53203', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Wisconsin AIDS Research Consortium', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Downtown Infectious Diseases Clinic', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster Univ Med Ctr', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Science Ctr', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Clinique Medicale du Quartier Latin', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Clinique Medicale L'Actuele", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Hospital General De Mexico', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Hospital Regional', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Instituto Nacional de Enfermedades Respiratorias', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Instituto Nacional de la Nutricion', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '00732', 'city': 'Ponce', 'country': 'Puerto Rico', 'facility': 'Ponce School of Medicine', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}, {'zip': '00909', 'city': 'Santruce', 'country': 'Puerto Rico', 'facility': 'Hepatology / Infectious Diseases'}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Program on AIDS / Thai Red Cross Society', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Ramathibodi Hosp', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj Hosp / Mahidol Univ', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Khonkaen', 'country': 'Thailand', 'facility': 'Khonkaen Univ'}], 'overallOfficials': [{'name': 'Michael Giordano', 'role': 'STUDY_DIRECTOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}}}}