HIV-1 MedDRA version: 28.0 Level: PT Classification code 10020185 Term: HIV test System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Biktarvy
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BICTEGRAVIR SODIUM
CAS Number: 1611493-60-7
Other descriptive name: BICTEGRAVIR SODIUM
Concentration unit: mg milligra
Sponsors
Fundació Clínic per a la Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years old. 2. Having confirmed HIV-1 positive test. 3. Patients not previously treated with antiretroviral treatment (post-exposure prophylaxis will be allowed if not done in the previous 6 months). 4. Clinically stable patients, in the opinion of the investigator, at the time of inclusion. 5. 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. 6. Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women at the time of the study inclusion or anticipating pregnancy during the follow-up period. 2. Suspicion of an active opportunistic infection that defers initiating antiretroviral treatment > 7 days since HIV confirmation. 3. Known hypersensitivity or intolerance of any of the components of Biktarvy®. 4. Patients on treatment with any prohibited medication (see section 5.2: Concomitant, nonpermitted and permitted medication). 5. Suspicion of transmitted HIV infection with probable resistance to second generation integrase inhibitors (source of infection with known mutations or low medication adherence with a strand transfer integrase inhibitor). 6. Any condition which, in the opinion of the principal investigator, may interfere with adequate understanding, cooperation or compliance with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the number of patients with the presence of any criteria that contraindicates the start of any antiretroviral regimen within the first week since the HIV confirmation.;Secondary Objective: 1.Feasibility to use Biktarvy as a rapid initiation strategy within seven days since the first visit in the HIV unit after HIV confirmation 2.Time since first HIV test was performed until initiation of Biktarvy 3.Time since HIV confirmation until initiation of Biktarvy 4.Virologic efficacy at 4, 24 and 48 weeks 5.Immunological response at 24 and 48 weeks 6.Systemic inflammatory and coagulation response evaluated by a large array of soluble markers of inflammation and coagulation at 48 weeks 7.Senescence response evaluated by a large array of soluble markers of senescence at 24 and 48 weeks 8.Retention in care in newly HIV diagnosed patients at 24 and 48 weeks 9.Incidence of subclinical obesity at 48 weeks 10.Treatment-related adverse events at 48 weeks 11.Number of discontinuations of treatment due to adverse events at 48 weeks 12.Treatment adherence through the SMAQ questionnaire at 48 weeks 13.Patient perception through the CESTA questionnaire at 48 weeks;Primary end point(s): Proportion of patients non-eligible to receive any of the antiretroviral regimens within the first week since the HIV confirmation) due to one or more of the following criteria at week 4: - Presence of HLA-B* 5701 or lack of HLA test - Presence of HIV genotypic resistance mutations to at least one class of ARV drug that decrease efficacy of antiretroviral treatment - CD4 count 100.000 copies/mL - 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), - 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 web | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of patients who start Biktarvy within the first week since HIV confirmation at the first visit at the HIV unit. 2. Time measured in Ddays since first HIV test was performed until Biktarvy is initiated. 3. Time measured in dDays since HIV confirmation (first visit at the HIV unit) until Biktarvy is initiated. 4. Proportion of patients with plasma viral load (VIH-1 RNA) < 50 copies/mL at 4, 12, 24 and 48 weeks. 5. Changes from week 0 in CD4 and CD8 count and CD4/CD8 ratio at 24 and 48 weeks. 6. 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. 7. 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. 8. Proportion of patients who attend all the study visits (including blood collection) at 24 and 48 weeks. 9. Changes from week 0 in subclinical obesity using dual x-ray absorptiometry at 48 weeks. 10. Proportion of patients with treatment-related adverse events during the study period. 11. Proportion of patients who discontinue study treatment due to adverse events at 48 weeks. 12. Changes in treatment adherence using the Simplified Medication Adherence Questionnaire at each visit during all the study period. 13. Patient perception of rapid start of Biktarvytherapy using a specific questionnaire (CESTA) at 48 weeks.;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Countries
Spain
Contacts
Public ContactBerta Torres
Hospital Clínic
Outcome results
None listed