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RECRUITING
NCT06774872
PHASE2

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

Sponsor: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

408

Start Date

2025-04-30

Completion Date

2028-06-15

Last Updated

2025-06-11

Healthy Volunteers

No

Conditions

Interventions

DRUG

Doravirine 100Mg Tab and Lamivudine 300 Mg Tab

Participants 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

DRUG

Dolutegravir 50mg Tab and Lamivudine 300 Mg Tab

Participants randomised in the "arm 2" will receive the DTG/3TC combination: dolutegravir 50 mg/lamivudine 300 mg (DOVATO®) 1 pill a day

Locations (1)

Hôpital Pitié-Salpêtrière

Paris, Île-de-France Region, France