Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2026-01-19 @ 2:16 PM
Study NCT ID:
NCT03033368
Status:
UNKNOWN
Last Update Posted:
2017-01-26
First Post:
2016-10-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rilpivirine in Virologically Suppressed Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068696', 'term': 'Rilpivirine'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-24', 'studyFirstSubmitDate': '2016-10-22', 'studyFirstSubmitQcDate': '2017-01-24', 'lastUpdatePostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of adolescents with HIV-RNA <50 copies/ml at 48 weeks after switching.', 'timeFrame': '48 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in neuropsychiatric test scores', 'timeFrame': 'Baseline and week 24', 'description': 'Using Trail Making Test and Coding subtest of WISC-III Wisconsin Card Sorting Test (WCST) Non-verbal part of Standard Progressive Matrices'}, {'measure': 'Change in quality of life (QOL) score', 'timeFrame': 'Baseline, week 4 and week 24', 'description': 'Using PedsQLTM 4.0'}, {'measure': 'Change in lipid profiles after switching to RPV-containing regimens', 'timeFrame': 'Baseline, week 24, and week 48', 'description': 'Measure cholesterol (mg/dl), LDL (mg/dl), HDL (mg/dl), triglyceride (mg/dl)'}, {'measure': 'Change in fasting blood sugar after switching to RPV-containing regime', 'timeFrame': 'Baseline, week 24, and week 48', 'description': 'Measue fasting blood sugar (mg/dl)'}, {'measure': 'Intensive PK parameter (Area under the plasma concentration-time curve; AUC0-24) of RPV in 20 subjects at 4 weeks after switching to RPV-containing regimens.', 'timeFrame': 'week 4', 'description': 'Measure area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24): unit; ng.h/ml'}, {'measure': 'Intensive PK parameter (maximum observed concentration of drug in plasma ;(Cmax) ) of RPV in 20 subjects at 4 weeks after switching to RPV-containing regimens.', 'timeFrame': 'week 4', 'description': 'Measue maximum observed concentration of drug in plasma (Cmax) : unit; ng/ml'}, {'measure': 'Intensive PK parameter (Minimum concentration of drug in plasma; (Ctrough)) of RPV in 20 subjects at 4 weeks after switching to RPV-containing regimens.', 'timeFrame': 'week 4', 'description': 'Measure minimum concentration of drug in plasma (Ctrough) : unit; ng/ml'}, {'measure': 'Description of resistance mutations in the adolescents with RPV treatment failure', 'timeFrame': 'baseline, week 12, week 24 and week 48', 'description': 'At any visit, if HIV-RNA is ≥1000 copies/ml, genotypic resistance testing will be performed. Using HIV-1 Antiretroviral drug resistance ViriSeq HIV-1 genotyping'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['immunological outcome', 'virologic outcomes', 'HIV-1 infected adolescents', 'EFV switch to RPV', 'Rilpivirine pharmacokinetic', 'neuropsychiatric adverse events'], 'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '28994660', 'type': 'DERIVED', 'citation': 'Jantarabenjakul W, Anugulruengkitt S, Kasipong N, Thammajaruk N, Sophonphan J, Bunupuradah T, Cressey TR, Colbers A, Burger DM, Phongsamart W, Puthanakit T, Pancharoen C; HIVNAT 220 study. Pharmacokinetics of rilpivirine and 24-week outcomes after switching from efavirenz in virologically suppressed HIV-1-infected adolescents. Antivir Ther. 2018;23(3):259-265. doi: 10.3851/IMP3198.'}]}, 'descriptionModule': {'briefSummary': 'To describe the immunologic and virologic outcomes (HIV RNA, CD4) following switching from EFV to RPV in virologically suppressed adolescents', 'detailedDescription': "Study Procedures:\n\nAt screening, the informed consent process will be provided to participant, or participant legally acceptable representatives before any study procedure. Only adolescents who know their HIV status will be asked to give assent.\n\nTwenty adolescents followed at HIV-NAT and the Department of Pediatrics, Faculty of Medicine, Chulalongkorn University will be asked to participate in the PK sub study. Participant who are enrolled in the PK substudy will be asked to take RPV in the morning after breakfast and then commence the PK evaluations after this witnessed dose. After the PK study at week 4, Participant will be followed with the other 80 adolescents until the end of the study. Participant will be asked to provide a small hair sample for RPV concentrations at weeks 4, 12, 24, and 48 after switching. This is an option therefore participant can refuse to provide their hair samples at any visits. HIV RNA levels will be performed at baseline, week 12, 24 and 48 visits. If the HIV-RNA at any visits is between \\>50 copies/ml, the HIV-RNA test will be repeated within 4-8 weeks with adherence improvement counseling. At any visit, if HIV-RNA is ≥1000 copies/ml, genotypic resistance testing will be performed. Modification of treatment both for resistance and safety consideration will be subject to the site principal investigator's decision."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* HIV-infected adolescents aged 12-18 years;\n* Body weight \\>25 kilograms;\n* Currently treated with stable EFV-based HAART (EFV plus two nucleoside or nucleotide reverse transcriptase inhibitors \\[N(t)RTI\\]) for \\>3 months prior to enrollment;\n* Plasma HIV RNA \\<50 copies/ml within the last 12 months;\n* ALT \\<200 IU/L within the last 12 months;\n* Caregivers give written informed consent and adolescents who know their HIV status (i.e., have been fully disclosed to) give assent\n\nExclusion Criteria:\n\n* Has evidence of NNRTI-associated resistance mutation(s) from previous genotypic resistance testing;\n* Currently has PI(s) in the HAART regimen;\n* Has currently active HIV-related infection(s), (The subject can be enrolled after the infection is under controlled);\n* Has significant medical problem(s) that would compromise study results (in the site principal investigator's opinion);\n* Pregnancy (postpartum women are allowed);\n* Concomitant treatment with drugs known to effect the PK of RPV (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin, omeprazole, esomeprazole, lansoprazole, erythromycin, clarithromycin, azithromycin, roxithromycin)"}, 'identificationModule': {'nctId': 'NCT03033368', 'briefTitle': 'Rilpivirine in Virologically Suppressed Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Treatment Switch From Efavirenz to Rilpivirine in Virologically-suppressed HIV-infected Thai Adolescents', 'orgStudyIdInfo': {'id': 'RPV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'opened label', 'description': 'Open-label, single-arm study, rilpivirine is the study drug', 'interventionNames': ['Drug: Rilpivirine']}], 'interventions': [{'name': 'Rilpivirine', 'type': 'DRUG', 'otherNames': ['Edurant'], 'description': 'Rilpivirine 25 mg tablet', 'armGroupLabels': ['opened label']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Investigator plan to the clinical data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'collaborators': [{'name': 'amfAR, The Foundation for AIDS Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}