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).
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;
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;
Pretherapeutic HIV-RNA genotype,
Parallel
Doravirine 100Mg Tab and Lamivudine 300 Mg Tab
DrugParticipants randomised in the "arm 1" will receive the DORAVIRINE/LAMIVUDINE combination: doravirine (PIFELTRO®) 100 mg 1 pill a day + lamivudine 300 mg 1 pill a day
Dolutegravir 50mg Tab and Lamivudine 300 Mg Tab
DrugParticipants randomised in the "arm 2" will receive the DTG/3TC combination: dolutegravir 50 mg/lamivudine 300 mg (DOVATO®) 1 pill a day
Measure the virological efficacy at week 48 to assess the effectiveness of the dual therapy to maintain the virological success to week 48
Measure ol plasma viral load assessed by RNA quantification using COBA 6800 system (Roch)
Click on the lead sponsor to view all of their trials.
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Lead sponsor
ANRS, Emerging Infectious Diseases
Collaborator
Organization providing support methodology coordination (Institut Pierre Louis d'Epidémiologie et de Santé Publique)
Collaborator
