MODULO

Korábbi kezelés

• Comedications leading to drug-drug interaction with one of the 3 study drugs (cf. detailed protocol);

Más betegség

• HIV-2 co-infection;
• Co-infection with hepatitis B virus (positive HBsAg and/or positive anti-HBc antibody with negative anti-HBs antibody);
• At least one resistance genotype is mandatory to include the patient: o If there was no virological failure under NRTI, NNRTI and INSTI in the past: - Pretherapeutic HIV-RNA genotype, - OR, in case of no available HIV-RNA genotype, genotype on proviral HIV-DNA to performed before inclusion, o In case of virological failure under NRTI, NNRTI and INSTI in the past: - HIV-RNA genotype at time of virological failure, - OR, in case of no available HIV-RNA genotype at time of failure, genotype on proviral HIV-DNA to performed before inclusion to be sure that the virus is fully sensitive to the study treatments, o Past virological failure is defined as: 2 consecutive pVL ≥50 copies/mL or one pVL ≥200 copies/mL, o Resistance genotypes will be interpretated with the last available ANRS algorithm.
• Any clinal condition limiting the participation in a clinical trial.

Életkor

• Pregnant or breastfeeding women, and women with age to be pregnant but refusing contraception;

Egyéb

• Documented resistance mutation or association of resistance mutations, associated with partial or full resistance to doravirine, dolutegravir or lamivudine, using the last version of the ANRS-MIE algorithm;
• Glomerular filtration rate <50 mL/min (CKD-EPI formula);

• Adults ≥18 years;
• Living with HIV-1;
• With pVL <50 copies/mL for at least 24 months;
• Under stable (7 days/7, 5 days/7 or 4 days/7) three-drug regimen including 2 NRTIs + 1 NNRTI or 1 INSTI or 1 boosted PI for at least 6 months;
• Affiliated to the French Social Insurance;
• Who have given their written consent to participate in the study.
• Patients with a DNA genotype in which the integrase gene could not be amplified, - And who have never been exposed to integrase inhibitors, - Or who have previously been exposed to integrase inhibitors, but without a history of virological failure;