Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:41 PM
Study NCT ID:
NCT01271894
Status:
COMPLETED
Last Update Posted:
2013-05-13
First Post:
2011-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Intensive Pharmacokinetics Sub-study of Encore1 (ENCORE1-PK)
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-10', 'studyFirstSubmitDate': '2011-01-05', 'studyFirstSubmitQcDate': '2011-01-05', 'lastUpdatePostDateStruct': {'date': '2013-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the pharmacokinetic parameters of EFV determined from blood collected over a 24-hour dosing interval in blinded samples from participants taking either 600 mg or 400 mg once daily in combination with Truvada.', 'timeFrame': '48 weeks'}], 'secondaryOutcomes': [{'measure': 'To compare the safety and tolerability of EFV 400 mg versus 600 mg given once daily.', 'timeFrame': '48 weeks'}, {'measure': 'To investigate the correlation between EFV concentration measurements from dried blood spots and concentration measured in matched plasma samples.', 'timeFrame': '48 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'efavirenz', 'pharmacokinetic'], 'conditions': ['HIV Infection']}, 'descriptionModule': {'briefSummary': 'Safety and efficacy are key issues in antiretroviral therapy (ART) selection. Efavirenz (EFV) is an important component of combination ART in treatment naive individuals. Like many drugs, there are inter-individual differences in the efficacy and tolerability of EFV. The Encore1 study provides an opportunity to examine the pharmacokinetics (PK)(processes by which a drug is absorbed, distributed, metabolized, and eliminated by the body) of EFV in blood samples collected over a 24-hour dosing interval in participants receiving either standard 600 mg or reduced 400 mg dose EFV once daily.', 'detailedDescription': 'This sub-study will investigate the relationships between dosage, EFV plasma concentrations, toxicity and virological efficacy. EFV concentrations in dried blood spots and matched plasma and will be evaluated to determine the utility of dried blood spot measurements in measuring EFV plasma concentrations. Measurements dried blood spots could potentially be a cheap and easy alternative to measurements in plasma. Dried blood spots can be easily collected from venous blood or fingerprick, do not need plasma separation and potentially need less stringent storage conditions during shipment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'All participants enrolled into the main Encore1 study at participating sub-study sites will be eligible to participate.\n\nParticipants must meet the following additional inclusion criteria prior to intensive pharmacokinetic assessment. Inclusion Criteria:\n\n* provide written sub-study consent at or before week 0\n* taken randomized study drugs for at least 4 weeks but less than 8 weeks\n* taken EFV in the evening for at least 7 days\n* taken all EFV doses over the 3 preceding days.'}, 'identificationModule': {'nctId': 'NCT01271894', 'briefTitle': 'The Intensive Pharmacokinetics Sub-study of Encore1 (ENCORE1-PK)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kirby Institute'}, 'officialTitle': 'The Intensive Pharmacokinetics Sub-study of Encore1: A Randomised, Double-blind, Placebo-controlled, Clinical Trial to Compare the Safety and Efficacy of Reduced Dose Efavirenz (EFV) With Standard Dose EFV Plus Two Nucleotide Reverse Transcriptase Inhibitors (N(t)RTI) in Antiretroviral-naïve HIV-infected Individuals Over 96 Weeks', 'orgStudyIdInfo': {'id': 'NCHECR-ENCORE1-PK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reduced dose Efavirenz arm', 'description': 'Participants randomized in main study to receive EFV (400 mg once daily; 2 x 200 mg + 1 x placebo once daily) plus tenofovir/emtricitabine (300/200 mg) fixed-dose combination once daily', 'interventionNames': ['Drug: Efavirenz']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normal Efavirenz dose arm', 'description': 'Patients randomized in the main study to receive EFV (600 mg once daily; 3 x 200 mg once daily) plus tenofovir/emtricitabine (300/200 mg) fixed-dose combination once daily', 'interventionNames': ['Drug: Efavirenz']}], 'interventions': [{'name': 'Efavirenz', 'type': 'DRUG', 'description': '600 mg once daily; given as 3 x 200 mg once', 'armGroupLabels': ['Normal Efavirenz dose arm']}, {'name': 'Efavirenz', 'type': 'DRUG', 'description': '400 mg once daily; given as 2 x 200 mg + 1 x placebo', 'armGroupLabels': ['Reduced dose Efavirenz arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital J.M. Ramos Mejia', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Desmond Tutu HIV Foundation', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Thai Red Cross-AIDS Research Centre, HIV-NAT Research Collaboration', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Chelsea and Westminister Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Marta Boffito, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chelsea & Westminster Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kirby Institute', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Chelsea and Westminster NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}