drugset / Trial / NCT06774872
Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Successfully
Phase 2
Recruiting
408 enrolled
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
ANRS, Emerging Infectious Diseases · collabOrganization providing support methodology coordination (Institut Pierre Louis d'Epidémiologie et de Santé Publique) · collab
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2025-04-30
- Primary completion
- 2027-01-15
- Completion
- 2028-06-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dolutegravir | Other / unclassified | 50 mg | — |
| Subject | Doravirine | Small molecule | 100 mg | — |
| Background | Lamivudine | Other / unclassified | 300 mg | — |