Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-28 @ 2:25 AM
Study NCT ID:
NCT04416906
Status:
COMPLETED
Last Update Posted:
2023-09-18
First Post:
2020-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Test and Treat Strategy in New HIV Diagnosis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000654125', 'term': 'bictegravir, emtricitabine, tenofovir alafenamide, drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is an open-label, single arm, single-centre prospective study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-15', 'studyFirstSubmitDate': '2020-06-02', 'studyFirstSubmitQcDate': '2020-06-02', 'lastUpdatePostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients non-eligible to receive any of the antiretroviral regimens within the first week since the HIV confirmation) at week 4', 'timeFrame': 'week 4', 'description': 'Patients will be considered non-eligible if they meet one or more of the following creiteria at week 4:\n\n* Presence of HLA-B\\* 5701 or lack of HLA test\n* Presence of HIV genotypic resistance mutations to at least one class of ARV drug that decrease efficacy of antiretroviral treatment\n* CD4 count \\< 200 cells/mm3\n* Viral load \\> 100.000 copies/mL\n* Comorbidities such as: Osteopenia measured by DXA (T score less than 1), medical history of cardiovascular risk measured by Framingham risk score \\> 10% at 10 years, Kidney function (eGFR \\<50mL/min),\n* Concomitant medication that can cause potential interactions with ARV (evaluating the risk of drug-drug interactions for drugs no totally safe (green colour) using the Liverpool website for DDI)\n* Hepatitis B (HBV) coinfection or lack of serology'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients who start Biktarvy within the first week since HIV confirmation at the first visit at the HIV unit.', 'timeFrame': 'week 4'}, {'measure': 'Days since first HIV test was performed until Biktarvy is initiated.', 'timeFrame': 'week 4'}, {'measure': 'Days since HIV confirmation (first visit at the HIV unit) until Biktarvy is initiated.', 'timeFrame': 'week 4'}, {'measure': 'Proportion of patients with plasma viral load (VIH-1 RNA) < 50 copies/mL at 4, 12, 24 and 48 weeks.', 'timeFrame': 'week 4, week 12, week 24 and week 48'}, {'measure': 'Changes from week 0 in CD4 and CD8 count and CD4/CD8 ratio at 24 and 48 weeks.', 'timeFrame': 'week 24 and week 48'}, {'measure': 'Changes from baseline in systemic inflammatory and coagulation response evaluated by measurement of soluble markers including, but not limited to IL-6, ultrasensitive PCR, Dimer-D at 48 weeks.', 'timeFrame': 'week 48'}, {'measure': 'Changes from baseline in senescence response evaluated by measurement of soluble markers of senescence including, but not limited to, bcl-2 apoptosis marker at 24 and 48 weeks.', 'timeFrame': 'week 24 and week 48'}, {'measure': 'Proportion of patients who attend all the study visits (including blood collection) at 24 and 48 weeks.', 'timeFrame': 'week 24 and week 48'}, {'measure': 'Changes from week 0 in subclinical obesity using dual x-ray absorptiometry at 48 weeks.', 'timeFrame': 'week 48'}, {'measure': 'Proportion of patients with treatment-related adverse events during the study period.', 'timeFrame': 'week 48'}, {'measure': 'Proportion of patients who discontinue study treatment due to adverse events at 48 weeks.', 'timeFrame': 'week 48'}, {'measure': 'Changes in treatment adherence using the Simplified Medication Adherence Questionnaire at each visit during all the study period.', 'timeFrame': 'week 48'}, {'measure': 'Patient perception of rapid start of Biktarvy therapy using a specific questionnaire (CESTA) at 48 weeks.', 'timeFrame': 'week 48'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV-1-infection']}, 'referencesModule': {'references': [{'pmid': '39045754', 'type': 'DERIVED', 'citation': 'Ugarte A, De La Mora L, De Lazzari E, Chivite I, Fernandez E, Inciarte A, Laguno M, Ambrosioni J, Solbes E, Berrocal L, Gonzalez-Cordon A, Martinez-Rebollar M, Foncillas A, Calvo J, Blanco JL, Martinez E, Mallolas J, Torres B. Rapid initiation of bictegravir/emtricitabine/tenofovir alafenamide as first-line therapy in HIV infection. A prospective study. J Antimicrob Chemother. 2024 Sep 3;79(9):2343-2353. doi: 10.1093/jac/dkae235.'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label, single arm, single-centre prospective study to evaluate the feasibility, efficacy and safety of a once daily fixed dose combination regimen, Biktarvy, as a rapid treatment strategy in newly HIV diagnosed patients that come for the first time to the Hospital Clínic HIV Unit Patients with confirmed HIV-1 diagnosis who wish to start ARV treatment immediately will receive bictegravir 50 mg + emtricitabine 200 mg + tenofovir alafenamide 25 mg within the first week since the HIV-1 confirmation during 48 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Having confirmed HIV-1 positive test.\n3. Patients not previously treated with antiretroviral treatment (post-exposure prophylaxis will be allowed if not done in the previous 6 months).\n4. Clinically stable patients, in the opinion of the investigator, at the time of inclusion.\n5. Women of child-bearing potential\\* must have a negative pregnancy test in urine before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: hormonal contraceptive methods intrauterine device, bilateral tubal occlusion, vasectomized partner or sexual abstinence.\n6. Written informed consent.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women at the time of the study inclusion or anticipating pregnancy during the follow-up period.\n2. Suspicion of an active opportunistic infection that defers initiating antiretroviral treatment \\> 7 days since HIV confirmation.\n3. Known hypersensitivity or intolerance of any of the components of Biktarvy®.\n4. Patients on treatment with any prohibited medication (see section 5.2: Concomitant, nonpermitted and permitted medication).\n5. Any condition which, in the opinion of the principal investigator, may interfere with adequate understanding, cooperation or compliance with the study.'}, 'identificationModule': {'nctId': 'NCT04416906', 'acronym': 'Test&Treat', 'briefTitle': 'A Test and Treat Strategy in New HIV Diagnosis.', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Clinic per a la Recerca Biomédica'}, 'officialTitle': 'A Test and Treat Strategy in Barcelona: A Prospective Study in New HIV Diagnosis.', 'orgStudyIdInfo': {'id': 'Biktarvy Test&Treat'}, 'secondaryIdInfos': [{'id': '2019-004837-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biktarvy', 'description': 'This is a fixed dose combination regimen containing 50 mg of Bictegravir + 200 mg of Emtricitabine + 25 mg of Tenofovir alafenamide.', 'interventionNames': ['Drug: Biktarvy']}], 'interventions': [{'name': 'Biktarvy', 'type': 'DRUG', 'description': 'Once daily fixed dose combination regimen of Biktarvy will be evaluated as a rapid treatment strategy in newly HIV diagnosed patients HIV diagnosed patients that come for the first time to the Hospital Clínic HIV Unit', 'armGroupLabels': ['Biktarvy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Torres Berta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic of Barcelona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'A plan description will be provided once it is decided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Judit Pich Martínez', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Research Manager', 'investigatorFullName': 'Judit Pich Martínez', 'investigatorAffiliation': 'Fundacion Clinic per a la Recerca Biomédica'}}}}