NCT06774872 Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Successfully

Trial Parameters

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Brief Summary

The main objective of the MODULO trial is to compare (non-inferiority) the capacity of DOR/3TC and DTG/3TC two-drug regimens of maintain virological success at W48 in people living with HIV virus ( PLWH) with suppressed HIV plasma viral load (pVL) under three-drug regimen at inclusion. The virological success is defined as no virological failure (2 consecutive pVL ≥50 copies/mL or one pVL ≥50 copies/mL followed with discontinuation of treatment or follow-up).

Eligibility Criteria

Inclusion Criteria: * Adults ≥18 years; * Living with HIV-1; * With pVL \<50 copies/mL for at least 24 months; * Under stable three-drug regimen including 2 NRTIs + 1 NNRTI or 1 INSTI or 1 boosted PI for at least 12 months; * Affiliated to the French Social Insurance; * Who have given their written consent to participate in the study Exclusion Criteria: * HIV-2 co-infection; * Co-infection with hepatitis B virus (positive HBsAg and/or positive anti-HBc antibody with negative anti-HBs antibody); * Documented resistance mutation or association of resistance mutations, associated with partial or full resistance to doravirine, dolutegravir or lamivudine; * At least one resistance genotype is mandatory to include the patient: * 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, * In case of virological failure under NRTI, NN

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