Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT00280969
Status:
COMPLETED
Last Update Posted:
2015-03-30
First Post:
2006-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing the Effectiveness Between Ritonavir Boosted Atazanavir and Efavirenz for the First HIV Treatment
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': 'C098320', 'term': 'efavirenz'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-27', 'studyFirstSubmitDate': '2006-01-22', 'studyFirstSubmitQcDate': '2006-01-23', 'lastUpdatePostDateStruct': {'date': '2015-03-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antiretroviral effect at the 48th week', 'timeFrame': '48 weeks'}], 'secondaryOutcomes': [{'measure': '1. Evaluation of immunological effect and safety in 48 weeks.', 'timeFrame': '48 weeks'}, {'measure': '2.Evaluation of antiretroviral effect, immunological effect and safety in 49 to 96 weeks.', 'timeFrame': '96 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV infection', 'treatment', 'efavirenz', 'atazanavir', 'ritonavir'], 'conditions': ['HIV Infection']}, 'referencesModule': {'references': [{'pmid': '21467701', 'type': 'RESULT', 'citation': 'Honda M, Ishisaka M, Ishizuka N, Kimura S, Oka S; Japanese Anti-HIV-1 QD Therapy Study Group. Open-label randomized multicenter selection study of once daily antiretroviral treatment regimen comparing ritonavir-boosted atazanavir to efavirenz with fixed-dose abacavir and lamivudine. Intern Med. 2011;50(7):699-705. doi: 10.2169/internalmedicine.50.4572. Epub 2011 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'A selection study in treatment naive HIV patients to compare the virologic success rate of once daily antiretroviral treatment regimens at the 48th week with Epzicom(lamivudine and abacavir) plus efavirenz and Epzicom plus ritonavir boosted atazanavir. The superior regimen will be hired to the comparative study to the current first line regimen (tenofovir plus lamivudine plus efavirenz)', 'detailedDescription': 'A selection study in treatment naive HIV patients to compare the virologic success rate of once daily antiretroviral treatment regimens at the 48th week with Epzicom(lamivudine and abacavir) plus efavirenz and Epzicom plus ritonavir boosted atazanavir. The superior regimen will be hired to the comparative study to the current first line regimen (tenofovir plus lamivudine plus efavirenz)\n\nThe primary endpoint is antiretroviral effect at the 48th week.\n\nThe secondary endpoint is;1. Evaluation of immunological effect and safety in 48 weeks. 2.Evaluation of antiretroviral effect, immunological effect and safety in 49 to 96 weeks.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* serological diagnosis of HIV infection\n* male aged over 20 years old\n* CD4 at enrollment between 100 to 300\n* body weight over 40kg\n* enable to obtain the written informed consent\n\nExclusion Criteria:\n\n* Patients who are considered unable to complete 48 weeks of study by their physician.\n* Patients who have gastrointestinal symptom which may interfere the absorption of antiretrovirals, or have swallowing problems.\n* Patients who have the history of hypersensitivity with lamivudine.\n* Hepatitis B carrier.\n* Blood test results within 4 weeks prior to the randomization; hemoglobin less than 9g/dl, platelet less than 50,000/mm3, neutrophils less than 1000/mm3, serum total bilirubin more than 2.0mg/dl, GOT/GPT/LDH more than two times of upper normal limit, serum creatinine more than 1.2mg/dl.\n* Patients who have had radiation or chemotherapy within 4 weeks prior to the randomization or will have the treatment during the study .\n* Patients who have had immunomodulating agent such as systemic use of corticosteroid or interferon within 4 weeks prior to the randomization. Inhaled corticosteroid is the exception.\n* Patients who have diabetes, congestive heart failure, cardiomyopathy, or other serious medical condition.\n* Patients with AIDS defining illness.\n* Patients with known resistant strains to efavirenz, atazanavir, ritonavir, lamivudine and abacavir prior to the study.\n* Patients with acute retroviral syndrome.\n* Patients with psychiatric disorder.\n* Patients whose physician consider the study enrollment inappropriate.'}, 'identificationModule': {'nctId': 'NCT00280969', 'briefTitle': 'Comparing the Effectiveness Between Ritonavir Boosted Atazanavir and Efavirenz for the First HIV Treatment', 'organization': {'class': 'OTHER_GOV', 'fullName': 'International Medical Center of Japan'}, 'officialTitle': 'Open-label Randomized Multicenter Study of Once Daily Antiretroviral Treatment Regimen Comparing Ritonavir Boosted Atazanavir to Efavirenz', 'orgStudyIdInfo': {'id': 'QD001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'atazanavir arm', 'description': 'Patients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom.', 'interventionNames': ['Drug: atazanavir arm']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'efavirenz arm', 'description': 'Patients are treated with efavirenz 300mg along with Epzicom.', 'interventionNames': ['Drug: efavirenz']}], 'interventions': [{'name': 'atazanavir arm', 'type': 'DRUG', 'description': 'Patients are treated with ritonavir 100mg boosted atazanavir 300mg along with Epzicom.', 'armGroupLabels': ['atazanavir arm']}, {'name': 'efavirenz', 'type': 'DRUG', 'description': 'Patients are treated with efavirenz 300mg along with Epzicom.', 'armGroupLabels': ['efavirenz arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '162-8655', 'city': 'Shinjuku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'International Medical Center of Japan', 'geoPoint': {'lat': 35.69115, 'lon': 139.70854}}], 'overallOfficials': [{'name': 'Shinichi Oka, M.D., phD.', 'role': 'STUDY_CHAIR', 'affiliation': 'International Medical Center of Japan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Medical Center of Japan', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Ministry of Health, Labour and Welfare, Japan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director general, AIDS Clinical Center', 'investigatorFullName': 'Shinichi Oka, M.D.', 'investigatorAffiliation': 'International Medical Center of Japan'}}}}