HIV Seropositivity
Conditions
Keywords
HIV, new diagnosis, Biktarvy
Brief summary
Evaluation of antiretroviral treatment adherence using determination of Bictegravir, Emtricitabine and Tenofovir with new HIV patients in France
Detailed description
* Patient treated at the first clinical contact * 18 sites (hospitals) in France * Treatment during 48 weeks with principal objective at W24 (plasma HIV-RNA \< 50 copies/ml) * Evaluation of antiretroviral treatment adherence using determination of Bictegravir, Emtricitabine and Tenofovir in hair sample
Interventions
DRUGBiktarvy arm
BIKTARVY : one tablet QD, every day between D0 and M12 includind - TAF (25mg) / FTC (200mg) / BICTEGRAVIR (50mg)
Sponsors
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pilot study, single arm, multicentric, national
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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 |
|---|---|
| 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) | virological suppression at Month 6 (M6) |
Secondary
| Measure | Time frame |
|---|---|
| proportion of participants with plasma HIV-RNA < 50 copies/ml | Month 1 (M1), Month 3 (M3), Month 6 (M6), Month 9 (M9), Month 12 (M12) |
| change in CD4 T cell count | between DAY 0 (D0) and Month 3 (M3), Month 6 (M6) and Month 12 (M12) |
| change in CD4/CD8 ratio | between DAY 0 (D0) and Month 6 (M6) and Month 12 (M12) |
| 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 | Between DAY 0 (D0) and Month 12 (M12) |
| proportion of participants experiencing a grade 3-4 adverse event (related or not related to study treatment) | Between DAY 0 (D0) and Month 12 (M12) |
| 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) | Between Month 6 (M6) and Month 12 (M12) |
| proportion of participants harboring a virus developing resistance-associated mutations at the time of protocol-defined virological failure | Between Month 6 (M6) and Month 12 (M12) |
| proportion of participants with a false positive HIV screening test (i.e. a first positive test that has not been confirmed) | DAY 0 (D0) |
| adherence to study treatment evaluated by drug concentrations measurement in hair | Month 1 (M1), Month 3 (M3), Month 6 (M6) and Month 12 (M12) |
| 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) | Between DAY 0 (D0) and Month 12 (M12) |
| participants' acceptability of immediate antiretroviral initiation treatment (self-assessed auto-questionnaires | At Day 0 (D0), Month 3 (M3), Month 6 (M6) and Month 12 (M12) |
| adherence to study treatment evaluated by (i) self-assessed auto-questionnaires (4-day recall), | Month 1 (M1), Month 3 (M3), Month 6 (M6) and Month 12 (M12) |
| adherence to study treatment evaluated by drug concentrations measurement in plasma | Month 1 (M1), Month 3 (M3), Month 6 (M6) and Month 12 (M12) |
| type of comedications used during the 12-months study period | Between DAY 0 (D0) and Month 12 (M12) |
| number of comedications used during the 12-months study period | Between DAY 0 (D0) and Month 12 (M12) |
Countries
France
Contacts
Primary ContactAIDA AB BENALYCHERIF
Backup ContactKARINE KA AMAT
Outcome results
None listed