HIV MedDRA version: 20.0 Level: LLT Classification code 10001509 Term: AIDS System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Bictarvy
Product Name: Bictarvy
Pharmaceutical Form: Tablet
INN or Proposed INN: Bictegravir
Other descriptive name: BICTEGR
Sponsors
Fundación SEIMC-GESIDA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Men and women = 18 years - Confirmed and documented diagnosis of HIV-1 infection - Virological suppression of more than 48 weeks (confirmed with HIV RNA 48 weeks) with DTG + 3TC - Signed informed consent - Negative pregnancy test (only women of childbearing age). A woman of childbearing age is considered to be a woman who has not undergone permanent infertility procedures or who has been amenorrheic for less than 12 months. 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 234 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Impossibility of obtaining written informed consent to participate in the study - Pregnant or lactating women or those who intend to become pregnant during the study period and do not commit to using proven contraceptive methods - Any suspicion or confirmation of resistance to TAF, FTC, DTG or BIC. - Patients with known hypersensitivity to any excipient used with TAF, 3TC, FTC, DTG or BIC - Any autoimmune or chronic inflammatory disease - Use of immunomodulatory or immunosuppressive agents, including steroids - Chronic treatment with aspirin, statins and other anti-inflammatory agents - Any acute infection in the last 2 months - Estimated glomerular filtration rate (eGFR) <30 mg / ml / m2 measured by any of the available formulas. The determination of the eGFR of a routine preliminary analysis of = 12 weeks prior to the signing of the consent is allowed - Contraindication for the use of TAF - Clinical status of the patient in rapid deterioration or the researcher considers that there is no reasonable hope that the patient will complete the study - Simultaneous participation in another clinical trial or research study that requires the need for treatment with other drugs outside the study or interfere with the visits of the same. - Any situation that, in the investigator opinion, could interfere with the patient's ability to comply with the treatment guideline and the protocol evaluations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the levels plasma of sCD14 in patients who change from dual therapy ART to triple therapy vs patients who continue with dual therapy (DTG + 3TC) throughout the 96 weeks; Secondary Objective: - To evaluate the levels plasma levels biomarkers that predict the mortality during the treatment of HIV infection over 96 weeks: - Inflammation (signaling pathways of IL-6): Ultrasensitive C-reactive protein (PCR-us) - Activation of monocytes / macrophages: sCD163 - Induction IDO-1: kynurenine / tryptophan ratio - Coagulation: dimer D - Immunoactivation: CD4 / CD8 ratio - Compare the results of all biomarkers mentioned above between both treatment arms - Evaluate changes in viral suppression rate - Evaluate changes in the CD4 T cell count - Evaluate the longitudinal trajectories of plasma biomarkers and the CD4 / CD8 ratio. - To assess the safety and tolerability of the administration of triple therapy (BIC / FTC / TAF) as ART ;Primary end point(s): Changes in the concentration of sCD14 from the beginning of treatment until week 96.;Timepoint(s) of evaluation of this end point: Visita basal, semana 0,4,12,24, 36, 48, 60, 72, 84 y 96 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Changes in plasma biomarkers that predict mortality during the treatment of HIV infection, indicators of different pathways involved in HIV immunopathogenesis up to week 96: o Inflammation (signaling pathways of IL-6): PCR-us o Activation of monocytes / macrophages: sCD163 o IDO-1 induction: kynurenine / tryptophan ratio o Coagulation: dimer D o Immunoactivation: CD4 / CD8 ratio - Changes in the CD4 + lymphocyte count from the start of treatment until week 96. - Changes in viral suppression rates from the beginning of treatment until week 96. - Longitudinal trajectories of the plasmatic biomarkers and the CD4 / CD8 ratio from the beginning of treatment until week 96. - Evaluation of AAs and GAEs from the start of treatment until week 96 ; Timepoint(s) of evaluation of this end point: - Basal visit, week 0,23,24, 47, 48, 95 y 96 -Visita basal, semana 0,4,12,24, 36, 48, 60, 72, 84 y 96 | — |
Countries
Spain
Contacts
Public ContactMaria Yllescas
Fundacion SEIMC-GESIDA
Outcome results
None listed