HIV positive age > 18 years - newly diagnosed HIV-infected individual evidenced by any tests - antiretroviral-treatment naive - negative urine pregnancy test - willing to sign an informed written consent– - regular health insurance - willing to provide two distinct contact information (telephone number and/or email) in order to be easily reached if needed between Day 0 and Day 7
Conditions
Interventions
Trade Name: BIKTARVY
Pharmaceutical Form: Tablet
Sponsors
IMEA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - age > 18 years - newly diagnosed HIV-infected individual evidenced by any of the following tests: (i) positive self-test, (ii) positive HIV Rapid antibody test, (iii) positive HIV immunoassay (ELISA 4th generation) test - antiretroviral-treatment naive - negative urine pregnancy test for women of childbearing potential and willing to use effective contraception (mechanical or medicamental) - willing to sign an informed written consent– - regular health insurance - willing to provide two distinct contact information (telephone number and/or email) in order to be easily reached if needed between Day 0 and Day 7 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 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - clinical symptoms suggestive of opportunistic infections - participant not willing to provide two distinct contact information - a woman who is pregnant or breast-feeding or planning to become pregnant during the expected study period. - Co-medication with deleterious interaction with study treatment (eg enzyme inducer)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To achieve virological suppression (plasma HIV-RNA < 50 copies/ml) at Week 24 on study treatment with a first-line treatment with TAF / FTC/ BIC initiated at the first clinical contact (Snapshot method); Secondary Objective: proportion of participants with a false positive HIV screening test proportion of participants with plasma HIV-RNA < 50 copies/ml change in CD4 T cell count, change in CD4/CD8 ratio proportion of participants requiring discontinuation/modification of TAF/FTC/Bictegravir proportion of participants experiencing a grade 3-4 adverse event proportion of participants with protocol defined virological failure proportion of participants harboring a virus developing resistance-associated mutations number and type of comedications used during the 48-week study period adherence to study treatment evaluated by self-assessed auto-questionnaires drug concentrations measurement in plasma and in hair, proportion of participants lost to follow-up throughout the 48-week study period - participants' acceptability of immediate cART initiation (self-assessed auto-questionnaires at visit D0, Week 12, Week 24 and Week 48) ;Primary end point(s): Proportion of participants with plasma RNA-HIV < 50 copies/mL at week 24;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - proportion of participants with a false positive HIV screening test (i.e. a first positive test that has not been confirmed) - proportion of participants with plasma HIV-RNA 400 copies/ml at Week 12 confirmed on a second sample drawn 15-21 days later, or two consecutive plasma HIV-RNA > 50 copies/ml within 15-21 days as of Week 24) - proportion of participants harboring a virus developing resistance-associated mutations at the time of protocol-defined virological failure - number and type of comedications used during the 48-week study period - adherence to study treatment evaluated by (i) self-assessed auto-questionnaires (4-day recall), (ii) drug concentrations measurement in plasma and in hair, - proportion of participants lost to follow-up throughout the 48-week study period (LFU = having missed more than two consecutive visits except for W24 and W48 visit) - participants' acceptability of immediate cART initiation (self-assessed auto-questionnaires at visit D0, Week 12, Week 24 and Week 48) ;Timepoint(s) of evaluation of this end point: D0,W12,W24 and W48 | — |
Countries
France
Contacts
Public ContactBENALYCHERIF
IMEA
Outcome results
None listed