Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-01-01 @ 12:36 AM
Study NCT ID:
NCT01189695
Status:
COMPLETED
Last Update Posted:
2013-05-13
First Post:
2010-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maintenance Boosted Lopinavir Monotherapy Following Salvage Protease-inhibitor (PI) Based Regimen in HIV With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Based Regimen Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-10', 'studyFirstSubmitDate': '2010-08-26', 'studyFirstSubmitQcDate': '2010-08-26', 'lastUpdatePostDateStruct': {'date': '2013-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to virological failure', 'timeFrame': '48 weeks', 'description': 'virological failure was defined as having two consecutive results of HIV-1 RNA \\>400 copies/ml in time separated by 4 weeks'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with virological suppression', 'timeFrame': '48 weeks', 'description': 'virological suppression defined as having HIV-1 RNA \\<40 copies/ml'}, {'measure': 'Proportion of patients with virological failure', 'timeFrame': '48 week', 'description': 'virological failure was defined as having two consecutive results of HIV-1 RNA \\>400 copies/ml in time separated by 4 weeks'}, {'measure': 'Time to loss of virological response (TLOVR)', 'timeFrame': '48 weeks', 'description': 'TLOVR was defined as time between randomization and the last value that HIV-1 RNA \\<40 copies/ml in a patient who initially suppressed HIV-1 RNA but subsequently demonstrated virologic rebound (two consecutive HIV-1 RNA \\>40 copies/ml)'}, {'measure': 'Change of CD4 cells count', 'timeFrame': '48 weeks', 'description': 'Change of CD4 cells count from start of study to Week 48'}, {'measure': 'Adverse events', 'timeFrame': '48 weeks', 'description': 'any grade 3 or grade 4 adverse events according to DAIDS AE grading table'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV or AIDS', 'Lopinavir', 'Ritonavir', 'Anti-Retroviral Agents', 'treatment failure', 'treatment experienced', 'NNRTI failure', 'monotherapy'], 'conditions': ['HIV', 'AIDS', 'Lopinavir', 'Treatment Failure']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine efficacy of ritonavir-boosted lopinavir monotherapy as a maintenance regimen in HIV-1-infected patients who previously failed Non-nucleoside reverse transcriptase inhibitors (NNRTI) based regimens and currently received salvage protease-inhibitor (PI) based regimens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-60 years\n* documented HIV infection\n* previously failed to NNRTI-based regimens\n* no history of failing PI-based regimens\n* receiving ritonavir-boosted PI + OBRs(such as NRITs, etravirine, raltegravir)\n* having HIV-1 RNA \\<50 copies/ml for at least prior 6 months\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman\n* HBV co-infection that had to treated with TDF, FTC or 3TC\n* had to received medications known to have potential significant drug interaction with LPV/r\n* life expectancy less than 6 months\n* serious systemic diseases such as liver cirrhosis Child-Pugh B/C, ESRD, malignancy\n* hemoglobin \\<8 g/dl, platelet \\<50,000/mm3, AST or ALT \\>3 ULN, estimated creatinine clearance \\<50 mL/min'}, 'identificationModule': {'nctId': 'NCT01189695', 'acronym': 'BIDI-MONO', 'briefTitle': 'Maintenance Boosted Lopinavir Monotherapy Following Salvage Protease-inhibitor (PI) Based Regimen in HIV With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Based Regimen Failure', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bamrasnaradura Infectious Diseases Institute'}, 'officialTitle': 'A Randomized Controlled Study Compares the 48 Weeks Results of HIV-1 RNA Between Ritonavir-boosted Lopinavir Monotherapy and Ritonavir-boosted Lopinavir + Optimized Background Regimens in HIV-1 Infected Patients Who Have HIV-1 RNA <50 Copies/ml More Than 6 Months While Receiving Salvage PI-based Regimen and Previously Failed NNRTI-based Regimen', 'orgStudyIdInfo': {'id': 'BIDI-MONO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Boosted lopinavir monotherapy', 'interventionNames': ['Drug: Ritonavir-boosted lopinavir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'boosted lopinavir + optimized background regimens (OBRs)', 'interventionNames': ['Drug: Ritonavir-boosted lopinavir', 'Drug: optimized background regimens (OBRs)']}], 'interventions': [{'name': 'Ritonavir-boosted lopinavir', 'type': 'DRUG', 'description': 'Lopinavir/ritonavir 200/50 mg every 12 hours', 'armGroupLabels': ['Boosted lopinavir monotherapy', 'boosted lopinavir + optimized background regimens (OBRs)']}, {'name': 'optimized background regimens (OBRs)', 'type': 'DRUG', 'description': 'Optimized background regimens such as NRTIs, etravirine or raltegravir', 'armGroupLabels': ['boosted lopinavir + optimized background regimens (OBRs)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11000', 'city': 'Nonthaburi', 'country': 'Thailand', 'facility': 'Bamrasnaradura Infectious Diseases Institute', 'geoPoint': {'lat': 13.86075, 'lon': 100.51477}}], 'overallOfficials': [{'name': 'Krittaecho Siripassorn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bamrasnaradura Infectious Diseases Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bamrasnaradura Infectious Diseases Institute', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Department of Disease Control, Thailand', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Krittaecho Siripassorn', 'investigatorAffiliation': 'Bamrasnaradura Infectious Diseases Institute'}}}}