Clinical Trial

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

Study acronym: MODULO
Recruiting Phase 2
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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).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-01-09; most recent amendment 2025-06-06.
Status change: Not Yet Recruiting → Recruiting 2025-05-21
Trial Details
NCT Number NCT06774872
Lead Sponsor Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Collaborators: ANRS, Emerging Infectious Diseases, Organization providing support methodology coordination (Institut Pierre Louis d'Epidémiologie et de Santé Publique)
Conditions HIV-1-infection
Enrollment 408 participants
Start Date 2025-04-30
Primary Completion 2027-01-15 (estimated)
Study Completion 2028-06-15 (estimated)
Updated on ClinicalTrials.gov 2025-06-11