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

NCT06774872 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2025-06-11

No results posted yet for this study

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).

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

Sponsors & Collaborators

  • ANRS, Emerging Infectious Diseases

    collaborator OTHER_GOV

  • Organization providing support methodology coordination (Institut Pierre Louis d'Epidémiologie et de Santé Publique)

    collaborator UNKNOWN

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

    lead OTHER

Principal Investigators

  • Romain PALICH, MD · Pitié-Salpêtrière Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2027-01-15
Completion
2028-06-15

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06774872 on ClinicalTrials.gov