Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2025-12-24 @ 2:04 PM
Study NCT ID:
NCT03512795
Status:
COMPLETED
Last Update Posted:
2024-02-23
First Post:
2018-04-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimization of HIV-1 DNA Genotyping by High Throughput Sequencing to Document Antiretroviral Resistant Mutations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-22', 'studyFirstSubmitDate': '2018-04-19', 'studyFirstSubmitQcDate': '2018-04-19', 'lastUpdatePostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '> Genotyping Score (GSS) comparison between HIV DNA-UDS genotyping assay obtained at inclusion and cumulative RNA-Sanger genotyping assays obtained at each virological failure during routine follow', 'timeFrame': 'baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV-1-infection']}, 'descriptionModule': {'briefSummary': 'The analysis of HIV resistance to antiretrovirals (Sanger sequencing on RNA) is difficult when the viral load is undetectable or during therapeutic breaks. In these situations, the ultra-deep sequencing (UDS) can be done on proviral DNA in order to improve characterization of archived resistant variants with may reflect past virological failures.\n\nThis study is a cross-sectional study which will require only one additional tube which can be taken during a routine check-up as part of the usual follow-up of the individuals included.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients living with HIV-1, with an undetectable viral load and a history of at least 2 virological failures in which resistance to at least two drug classes was observed', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who has given consent\n* Adult patient\n* Patient living with HIV-1\n* Controlled viral load (\\<50 RNA copies/ml) for at least 1 year.\n* At least two previous virologic failures, either :\n\n * Initial failure : defined as the persistence of a viral load greater than 50 copies/ml beyond 1 year, after the initiation of triple antiretroviral therapy, and without virological control (VL \\> 50 copies/ml) since the initiation of the very first antiretroviral treatment.\n * A rebound in HIV viral load to more than 50 copies/ml after a period of virological success, confirmed on two consecutive samples at least one month apart.\n* At least 2 Sanger RNA genotypes have been done or could be done from the existing library.\n\nExclusion Criteria:\n\n* Patient not affiliated to a medical insurance scheme\n* Protected adult\n* Pregnant, parturient or breastfeeding woman\n* Discontinuation of clinical and immuno-virological follow-up for more than 2 years'}, 'identificationModule': {'nctId': 'NCT03512795', 'acronym': 'Mutapro', 'briefTitle': 'Optimization of HIV-1 DNA Genotyping by High Throughput Sequencing to Document Antiretroviral Resistant Mutations', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Optimization of HIV-1 DNA Genotyping by High Throughput Sequencing to Document Antiretroviral Resistant Mutations', 'orgStudyIdInfo': {'id': 'BLOT AOI 2017'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood samples', 'type': 'BIOLOGICAL', 'description': "An additional blood tube will be taken during the patient's follow-up blood collection."}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Chu Dijon Bourogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}