Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France: Trial IMEA 055 - FAST

Browse trials for

• HIV Seropositivity 210

Keywords

• HIV, new diagnosis, Biktarvy

HIV Seropositivity

210 studies on the registry are indexed under HIV Seropositivity; 10 are open to participants now.

This study's planned enrollment of 110 is above the median of 89 across 140 interventional studies indexed under HIV Seropositivity.

Lead sponsor

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba is the lead sponsor of 23 studies on the registry; 4 are open to participants now.

Study arms

• Experimental
  Biktarvy arm

  one tablet of BIKTARVY including \[TAF (25mg) / FTC (200mg) / BICTEGRAVIR (50mg) \] one tablet once a day for 48 weeks

  Drug: Biktarvy arm

Interventions

• DrugBiktarvy arm

  BIKTARVY : one tablet QD, every day between D0 and M12 includind - TAF (25mg) / FTC (200mg) / BICTEGRAVIR (50mg)

Primary outcomes

1. To achieve virological suppression (plasma HIV-RNA < 50 copies/ml) at Month 6 (M6)on study treatment with a first-line treatment with TAF / FTC/ BIC initiated at the first clinical contact (Snapshot method)

   Time frame: virological suppression at Month 6 (M6)

Secondary outcomes

1. proportion of participants with a false positive HIV screening test (i.e. a first positive test that has not been confirmed)

   Time frame: DAY 0 (D0)

2. proportion of participants with plasma HIV-RNA < 50 copies/ml

   Time frame: Month 1 (M1), Month 3 (M3), Month 6 (M6), Month 9 (M9), Month 12 (M12)

3. change in CD4 T cell count

   Time frame: between DAY 0 (D0) and Month 3 (M3), Month 6 (M6) and Month 12 (M12)

4. change in CD4/CD8 ratio

   Time frame: between DAY 0 (D0) and Month 6 (M6) and Month 12 (M12)

5. proportion of participants requiring discontinuation/modification of TAF/FTC/Bictegravir due to (i) Baseline resistance to one of the study drugs, (ii) adverse events leading to study treatment discontinuation/Modification

   Time frame: Between DAY 0 (D0) and Month 12 (M12)

6. proportion of participants experiencing a grade 3-4 adverse event (related or not related to study treatment)

   Time frame: Between DAY 0 (D0) and Month 12 (M12)

7. proportion of participants with protocol defined virological failure (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)

   Time frame: Between Month 6 (M6) and Month 12 (M12)

8. proportion of participants harboring a virus developing resistance-associated mutations at the time of protocol-defined virological failure

   Time frame: Between Month 6 (M6) and Month 12 (M12)

9. number of comedications used during the 12-months study period

   Time frame: Between DAY 0 (D0) and Month 12 (M12)

10. adherence to study treatment evaluated by drug concentrations measurement in hair

    Time frame: Month 1 (M1), Month 3 (M3), Month 6 (M6) and Month 12 (M12)

11. proportion of participants lost to follow-up throughout the 12-months study period (LFU = having missed more than two consecutive visits except for W24 and W48 visit)

    Time frame: Between DAY 0 (D0) and Month 12 (M12)

12. participants' acceptability of immediate antiretroviral initiation treatment (self-assessed auto-questionnaires

    Time frame: At Day 0 (D0), Month 3 (M3), Month 6 (M6) and Month 12 (M12)

13. adherence to study treatment evaluated by (i) self-assessed auto-questionnaires (4-day recall),

    Time frame: Month 1 (M1), Month 3 (M3), Month 6 (M6) and Month 12 (M12)

14. adherence to study treatment evaluated by drug concentrations measurement in plasma

    Time frame: Month 1 (M1), Month 3 (M3), Month 6 (M6) and Month 12 (M12)

15. type of comedications used during the 12-months study period

    Time frame: Between DAY 0 (D0) and Month 12 (M12)