MODULO Trial: Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Successfully Treated With Three-drug Regimens at Inclusion
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
Hôpital Pitié-Salpêtrière
RECRUITING
Paris
Contact Information
Primary
Yasmine DUDOIT
yasmine.dudoit@aphp.fr
+33 (0)142164181
Backup
Romain PALICH, MD
romain.palich@aphp.fr
+33 (0)142160171
Time Frame
Start Date:2025-04-30
Estimated Completion Date:2028-06-15
Participants
Target number of participants:408
Treatments
Experimental: DORAVIRINE/LAMIVUDINE combination
Patients randomized to arm 1 will receive the DORAVIRINE/LAMIVUDINE combination: doravirin (PIFELTRO®) 100 mg 1 tablet per day + lamivudine (generic) 300 mg 1 tablet per day~The dosage is in accordance with the summary of product characteristics of each product.
Patients randomized to arm 2 will receive the fixed combination DOLUTEGRAVIR/LAMIVUDINE: dolutegravir 50 mg/lamivudine 300 mg (DOVATO®) 1 tablet per day.~The dosage is in accordance with the summary of product characteristics of each product.
Collaborators: Organization providing support methodology coordination (Institut Pierre Louis d'Epidémiologie et de Santé Publique), ANRS, Emerging Infectious Diseases
Leads: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida