Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-02 @ 7:41 AM
Study NCT ID:
NCT00038532
Status:
COMPLETED
Last Update Posted:
2008-04-01
First Post:
2002-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART
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': 'C095108', 'term': 'amprenavir'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'D019258', 'term': 'Saquinavir'}, {'id': 'C098320', 'term': 'efavirenz'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011804', 'term': 'Quinolines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-04'}, 'statusVerifiedDate': '2006-07', 'lastUpdateSubmitDate': '2008-03-29', 'studyFirstSubmitDate': '2002-05-31', 'studyFirstSubmitQcDate': '2002-05-31', 'lastUpdatePostDateStruct': {'date': '2008-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-06-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects with plasma HIV RNA levels below the limit of quantification (400 copies/mL) at week 24 and the time until loss of virologic response through week 48'}]}, 'conditionsModule': {'keywords': ['treatment experienced', 'HIV'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study amprenavir/ritonavir, saquinavir/ritonavir or efavirenz in HIV-infected patients following failure with Kaletra (ABT-378/ritonavir) as their first protease inhibitor based HAART.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n* Remain on present anti-HIV drugs during screening until a new regimen is started.\n* Have a viral load of at least 1,000 copies/ml on the 2 most recent tests after at least 24 weeks of lopinavir/ritonavir and while still on it.\n* Have an HIV which shows reduced susceptibility to lopinavir.\n* Are at least 18 years old.\n* Are not presently ill.\n* Have not been treated for an opportunistic infection within 30 days of screening.\n* Agree not to take certain drugs and agree to inform and get permission from the doctor before taking any medicines, over the counter medicines, herbal medicines, alcohol or recreational drugs.\n* Agree to use an accepted barrier method of birth control.\n\nExclusion:\n\n* Female subject is pregnant or lactating.\n* Have taken any protease inhibitor other than lopinavir/ritonavir for more that two weeks.\n* Are taking chemotherapy.\n* Have a medical problem with their pancreas.\n* Have been screened for this study within the past 12 weeks.\n* Appear to be unsuitable in the opinion of the doctor.'}, 'identificationModule': {'nctId': 'NCT00038532', 'briefTitle': 'Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART', 'nctIdAliases': ['NCT00021619'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'An Open Label, Phase II Study of Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART', 'orgStudyIdInfo': {'id': 'M01-287'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Amprenavir/ritonavir', 'type': 'DRUG'}, {'name': 'Saquinavir/ritonavir', 'type': 'DRUG'}, {'name': 'Efavirenz', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Body Positive, Inc.', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92780', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Paul J. Cimoch, M.D.', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'AIDS Health Care Foundation - Research Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Tower Infectious Diseases Medical Associates', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80205', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': '20th Avenue Medical Center Kaiser Permanente', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Health Sciences Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32701', 'city': 'Altamonte Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'IDC Research Initiative', 'geoPoint': {'lat': 28.66111, 'lon': -81.36562}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Gary J. Richmond, M.D.', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Associates in Research', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Infectious Disease Research Institute, Inc.', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'AIDS Research Consortium of Atlanta, Inc.', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'CORE Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Donna E. Sweet, M.D.', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '63139', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'David Parks, M.D.', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07102', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': "Saint Michael's Medical Center", 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Howard A. Grossman, M.D.', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'John B. Montana, M.D.', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11794-08153', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'State University of New York at Stony Brook', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '45267-0405', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97209', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'The Research & Education Group', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19601', 'city': 'Reading', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Bornemann Internal Medicine', 'geoPoint': {'lat': 40.33565, 'lon': -75.92687}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'David Wright, M.D.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77555-0435', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77027', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Diversified Medical Practices, P.A.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23666', 'city': 'Hampton', 'state': 'Virginia', 'country': 'United States', 'facility': 'Hampton Roads Medical Specialists', 'geoPoint': {'lat': 37.02987, 'lon': -76.34522}}, {'zip': '4304-2180', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Muniz - FUNDAI', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '4981-1855', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Fundacion Huesped', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '01332-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Heliopolis', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Hospital General Campus', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G-2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto General Hospital Division of The University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2X 2PA', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Chest Institute/Royal Victoria Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'Hopital Michalon - C.H.U. de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '75679', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier Cochin -Saint-Vincent-de-Paul La Roche-Guyon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75970', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '22023', 'city': 'Saint-Brieuc', 'country': 'France', 'facility': 'Hospital Yves Le Foll', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}, {'zip': '83056', 'city': 'Toulon', 'country': 'France', 'facility': 'La Seyne sur Mer, Hopital Chalucet', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'C.H.U. Brabois - Tour Drouet, Rue du Morvan', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'CORE Center', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Universitatsklinikum', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '60596', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Klinikum J.W. Goethe Universitat', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '20099', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Institut fur Immunologie Pathologie und Molekularbiologie', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '70197', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Albrecht Ulmer, M.D.', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '20127', 'city': 'Milan', 'country': 'Italy', 'facility': 'S. Raffaele Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '01-201', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Wojewodzki Szpital Zakazny', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '00731', 'city': 'Ponce', 'country': 'Puerto Rico', 'facility': 'Centro Familiar, Inc', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}, {'zip': '00925', 'city': 'Rio Piedras', 'country': 'Puerto Rico', 'facility': 'New Puerto Rico CONCRA', 'geoPoint': {'lat': 18.39745, 'lon': -66.04989}}, {'zip': '08916', 'city': 'Badalona', 'country': 'Spain', 'facility': 'Hospital Germans Trias I Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital De La Sta Creu I San Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic I Provincial', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28010', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Carlos III', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Vergen del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': 'NW3 2QG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Free Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Eugene Sun, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Divisional Vice President, Infectious Diseases and Virology Development'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}}}}