Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-31 @ 1:16 PM
Study NCT ID:
NCT00335192
Status:
COMPLETED
Last Update Posted:
2008-09-08
First Post:
2006-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Determine if There Are Pharmacokinetic Interactions at Plasma or Intracellular Level Between Nucleosides and Tenofovir
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019259', 'term': 'Lamivudine'}, {'id': 'C558899', 'term': 'lopinavir-ritonavir drug combination'}, {'id': 'C036986', 'term': 'VBA protocol'}, {'id': 'C106538', 'term': 'abacavir'}], 'ancestors': [{'id': 'D016047', 'term': 'Zalcitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-05', 'studyFirstSubmitDate': '2006-06-08', 'studyFirstSubmitQcDate': '2006-06-08', 'lastUpdatePostDateStruct': {'date': '2008-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint will be the variation between the intracellular levels of 3TC and ABC before and after the interruption of the treatment with TDF', 'timeFrame': 'At baseline and week 4.'}], 'secondaryOutcomes': [{'measure': 'Variations between the plasma levels of 3TC and ABC before and after interruption of the treatment with TDF.', 'timeFrame': 'at baseline and week 4'}, {'measure': 'Correlation between the intracellular and plasma levels of 3TC, ABC and TDF.', 'timeFrame': 'at baseline and week 4'}, {'measure': 'Changes in the intracellular levels of TDF following the withdrawal of the drug.', 'timeFrame': 'At week 4.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intracellular concentrations', 'Plasma concentration', 'Abacavir', 'Tenofovir', 'Lamivudine (3TC)', 'Pharmacokinetic interactions'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate if there are pharmacokinetic interactions between the NRTI 3TC and ABV, and the TDF nucleotide. For this purpose, the intracellular and plasma levels of 3TC and ABV will be compared in patients given these nucleosides with TDF and 30 days after the interruption of the TDF.', 'detailedDescription': 'There is clear evidence of pharmacokinetic interaction between ddI+TDF. However, the interaction between TDF and other NRTIs, mainly at intracellular level, has not been so well studied.\n\nSince all the NRTIs are anabolized at intracellular level by numerous kinases, and are transported by passive carrier systems, the interaction may be between TDF and other NRTIs.\n\nThis study aims to investigate the pharmacokinetic interactions between the TDF and the nucleosides abacavir (ABV) and lamivudine (3TC) at plasma and intracellular level.\n\nWith this objective, intracellular and plasma levels will be analysed in a group of patients that receive the combinations 3TC +TDF, ABV+TDF and 3TC+ABV+TDF together with lopinavir/rtv or nevirapine. Subsequently, in a second phase of the study, in the group of patients given ABV and/or 3TC + TDF + lopinavir/rtv, the pharmacokinetic determinations will be repeated after a 4-week interruption of the TDF .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. HIV+ patients aged above 18 years.\n2. Undetectable HIV viral load in the last determination\n3. Patients capable of correct compliance according to clinical criteria.\n4. Patients on triple HAART therapy for the previous 3 months including 3TC and/or ABV and TDF, with a PI (Lopinavir/ritonavir) or an NNRTI (Nevirapine)\n5. Women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use a barrier contraceptive method during the study.\n6. Ability to provide informed consent.\n\nExclusion Criteria:\n\n1. Incorrect therapeutic compliance over the four weeks before the beginning of the study.\n2. Interruption or withdrawal from therapy during follow-up.\n3. Concomitant treatment with any drug which according to the clinician's criterion may interact with the investigational antiretrovirals, such as other antiretrovirals.\n4. Triple HAART therapy including Nevirapine (for phase II)\n5. Documented or suspected resistance to ABV, 3TC or lopinavir/rtv (for phase II)."}, 'identificationModule': {'nctId': 'NCT00335192', 'briefTitle': 'To Determine if There Are Pharmacokinetic Interactions at Plasma or Intracellular Level Between Nucleosides and Tenofovir', 'organization': {'class': 'OTHER', 'fullName': 'Germans Trias i Pujol Hospital'}, 'officialTitle': 'Determination of Plasma and Intracellular Levels of Nucleoside Reverse Transcriptase Inhibitors (NRTI) and of Nucleotide Analog Tenofovir Disoproxil Fumarate (TDF) in Patients Treated With Abacavir and/or Lamivudine Given With or Without TDF.', 'orgStudyIdInfo': {'id': 'INTRANUCS'}, 'secondaryIdInfos': [{'id': '2004-000948-25'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Phase I: 3TC + TDF + NVP or LPV/rtv\n\nPhase II: patients on treatment with LPV/rtv, stop TDF during 4 weeks: 3TC + LPV/rtv', 'interventionNames': ['Drug: Patients in treatment with 3TC + TDF + LPV/rtv, stop tenofovir during 4 weeks']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Phase I: ABV + TDF + NVP or LPV/rtv\n\nPhase II: patients on treatment with LPV/rtv, stop TDF during 4 weeks: ABV + LPV/rtv', 'interventionNames': ['Drug: Patients in treatment with ABV + TDF + LPV/rtv, stop tenofovir during 4 weeks']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Phase I: 3TC + ABV + TDF + NVP or LPV/rtv\n\nPhase II: patients on treatment with LPV/rtv, stop TDF during 4 weeks: 3TC + ABV + LPV/rtv', 'interventionNames': ['Drug: Patients in treatment with 3TC + ABV + TDF+ LPV/rtv, stop TDF during 4 weeks']}], 'interventions': [{'name': 'Patients in treatment with 3TC + TDF + LPV/rtv, stop tenofovir during 4 weeks', 'type': 'DRUG', 'otherNames': ['Epivir', 'Kaletra'], 'description': '3TC (300 mg/24 h, 1 tablet/24 h) + Lopinavir/ritonavir (400 mg/12 h, 3 tablets/12 h)', 'armGroupLabels': ['1']}, {'name': 'Patients in treatment with ABV + TDF + LPV/rtv, stop tenofovir during 4 weeks', 'type': 'DRUG', 'otherNames': ['Ziagen', 'Kaletra'], 'description': 'ABV (300 mg/12 h, 1 tablet/12 h)+ Lopinavir/ritonavir (400 mg/12 h, 3 tablets/12 h)', 'armGroupLabels': ['2']}, {'name': 'Patients in treatment with 3TC + ABV + TDF+ LPV/rtv, stop TDF during 4 weeks', 'type': 'DRUG', 'otherNames': ['Epivir', 'Ziagen', 'Kaletra'], 'description': '3TC (300 mg/24 h, 1 tablet/24 h)+ ABV (300 mg/12 h, 1 tablet/12 h)+ Lopinavir/ritonavir (400 mg/12 h, 3 tablets/12 h).', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}], 'overallOfficials': [{'name': 'Bonaventura Clotet, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LLuita contra la Sida Foundation-HIV Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Germans Trias i Pujol Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'LLuita Sida Foundation', 'oldOrganization': 'LLuita Sida Foundation'}}}}