Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT01160120
Status:
COMPLETED
Last Update Posted:
2020-07-17
First Post:
2010-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Therapeutic Drug Monitoring (TDM) in Generic Tenofovir/Lamivudine/Efavirenz
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-15', 'studyFirstSubmitDate': '2010-06-09', 'studyFirstSubmitQcDate': '2010-07-09', 'lastUpdatePostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mid levels of TDF, 3TC, and EFV between brand and generic', 'timeFrame': '144 weeks', 'description': 'mid levels of TDF, 3TC, and EFV between brand and generic'}], 'secondaryOutcomes': [{'measure': 'kidney, liver, CD4 and viral load overtime', 'timeFrame': '144 weeks', 'description': 'kidney, liver, CD4 and viral load overtime'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fixed dose combinations', 'tenofovir', 'lamivudine', 'efavirenz', 'therapeutic drug levels', 'safety and efficacy', 'HIV', 'To evaluation new formulations of FDC of TDF/3TC/EFV'], 'conditions': ['HIV']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Avihingsanon A, Sophonphan J, Thammajaruk N, Chaihong P, Burger D, Cressey TR, Ramautarsing RA, Praditornsilpa K, Avihingsanon Y, Ruxrungtham K and HIV-NAT 114 study team. Plasma Tenofovir Concentrations and Proximal Tubular Dysfunction in HIV-Infected Adults Receiving Tenofovir in Thailand. AIDS Clin Res 2015, 6:7 Doi: http://dx.doi.org/10.4172/2155-6113.1000477'}], 'seeAlsoLinks': [{'url': 'http://www.hivnat.org', 'label': 'HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the mid levels of the tenofovir, lamivudine, and efavirenz, and 144 weeks safety and efficacy of the generic fixed dose combination of tenofovir /lamivudine/efavirenz tablets 300/300/600 mg in Thai HIV-infected patients.', 'detailedDescription': 'The trial drug FDC of TDF/3TC/EFV is a new formulation combining fixed doses of the nucleoside reverse transcriptase inhibitors lamivudine 300 mg and tenofovir disoproxil fumarate 300 mg with the non nucleoside reverse transcriptase inhibitor efavirenz 600 mg for once daily and one-tablet HAART. Co-formulated TDF/3TC/EFV demonstrated bioequivalent to original individual EFV 3TC and TDF in Indian healthy volunteers (unpublished data). It has not been evaluated in clinical trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Evidence of HIV infection\n* Age\\> 18 years\n* On a TDF/3TC/EFV (separated pills) containing HAART regimen with a VL \\< 50 copies within 24 weeks or ARV naïve\n* eGFR \\>70 cc/min\n* Currently having no AIDS defining illness\n* No history of NRTI/NNRTI/PI failure\n* Willing to adhere to the protocol requirements\n\nExclusion Criteria:\n\n* Any history of taking CYP450 inhibitors or inducers drugs within 14 days of enrollment in the study\n* Current pregnancy or lactating or plan to be pregnant\n* Active opportunistic infection\n* ALT more than 2 x upper limit\n* Creatinine more than 1.5 time the upper limit\n* Active drug abuse'}, 'identificationModule': {'nctId': 'NCT01160120', 'briefTitle': 'Therapeutic Drug Monitoring (TDM) in Generic Tenofovir/Lamivudine/Efavirenz', 'organization': {'class': 'OTHER', 'fullName': 'The HIV Netherlands Australia Thailand Research Collaboration'}, 'officialTitle': 'Generic Fixed Dose Combination (FDC) of Tenofovir(TDF) /Lamivudine(3TC)/Efavirenz (EFV) Tablets 300/300/600 mg', 'orgStudyIdInfo': {'id': 'HIV-NAT 118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Patients can be either treatment-naïve or treatment-experienced when entering this clinical trial. After meeting the inclusion and exclusion criteria, patients will start with generic FDC of TDF/3TC/EFV 1 pill a day at night time. Only patient who are on individual TDF 3TC and EFV will undergo TDM sampling ( 11-13 hours after dosing) at baseline.', 'interventionNames': ['Drug: generic FDC of TDF/3TC/EFV']}], 'interventions': [{'name': 'generic FDC of TDF/3TC/EFV', 'type': 'DRUG', 'description': 'Patients who were on individual TDF 3TC and EFV regimen before baseline will undergo TDM at baseline. Therapeutic drug monitoring (TDM) of generic FDC of TDF/3TC/EFV will be done after 4 weeks, to ensure steady state. At baseline and week 4 safety data will be obtained. In order to assess the efficacy and the long term safety of this drug, at week 12, 24 and 48 viral load, CD4 and safety parameters will be obtained.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'HIV-NAT', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Anchalee Avihingsanon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The HIV Netherlands Australia Thailand Research Collaboration'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The HIV Netherlands Australia Thailand Research Collaboration', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mylan Laboratories', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}