Fact CheckerSign in

NCT06774872RecruitingPhase 3

MODULO

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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Jul 2026

Brief summary (registry, in English)

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 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).

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
408 (estimated)
First submitted
17 Sept 2024
Start date
30 Apr 2025
Lead sponsor
Centre De Recherches Et D'Etudes Sur La Pathologie Tropicale Et Le Sida
Diseases
HIV
NCT number
NCT06774872
EU CT number
2024-515793-27-01

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 408
  • 36 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Comedications leading to drug-drug interaction with one of the 3 study drugs (cf. detailed protocol);

Other illness

  • HIV-2 co-infection;
  • Co-infection with hepatitis B virus (positive HBsAg and/or positive anti-HBc antibody with negative anti-HBs antibody);
  • At least one resistance genotype is mandatory to include the patient: o If there was no virological failure under NRTI, NNRTI and INSTI in the past: - Pretherapeutic HIV-RNA genotype, - OR, in case of no available HIV-RNA genotype, genotype on proviral HIV-DNA to performed before inclusion, o In case of virological failure under NRTI, NNRTI and INSTI in the past: - HIV-RNA genotype at time of virological failure, - OR, in case of no available HIV-RNA genotype at time of failure, genotype on proviral HIV-DNA to performed before inclusion to be sure that the virus is fully sensitive to the study treatments, o Past virological failure is defined as: 2 consecutive pVL ≥50 copies/mL or one pVL ≥200 copies/mL, o Resistance genotypes will be interpretated with the last available ANRS algorithm.
  • Any clinal condition limiting the participation in a clinical trial.

Age

  • Pregnant or breastfeeding women, and women with age to be pregnant but refusing contraception;

Other

  • Documented resistance mutation or association of resistance mutations, associated with partial or full resistance to doravirine, dolutegravir or lamivudine, using the last version of the ANRS-MIE algorithm;
  • Glomerular filtration rate <50 mL/min (CKD-EPI formula);

Who the study is looking for

  • Adults ≥18 years;
  • Living with HIV-1;
  • With pVL <50 copies/mL for at least 24 months;
  • Under stable (7 days/7, 5 days/7 or 4 days/7) three-drug regimen including 2 NRTIs + 1 NNRTI or 1 INSTI or 1 boosted PI for at least 6 months;
  • Affiliated to the French Social Insurance;
  • Who have given their written consent to participate in the study.
  • Patients with a DNA genotype in which the integrase gene could not be amplified, - And who have never been exposed to integrase inhibitors, - Or who have previously been exposed to integrase inhibitors, but without a history of virological failure;

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (36)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Universitaire D'Angers
Coordinator of this site? Confirm its status
AngersFranceRecruiting
Centre Hospitalier Victor Dupouy
Coordinator of this site? Confirm its status
Argenteuil CedexFranceRecruiting
Hopital Avicenne
Coordinator of this site? Confirm its status
BobignyFranceRecruiting
Centre hospitalier Universitaire de Bordeaux
Coordinator of this site? Confirm its status
BordeauxFranceRecruiting
Centre Hospitalier Universitaire De Bordeaux
Coordinator of this site? Confirm its status
Bordeaux CedexFranceRecruiting
Hôpital Ambroise-Paré
Coordinator of this site? Confirm its status
Boulogne-BillancourtFranceRecruiting
Hopital Antoine Beclere
Coordinator of this site? Confirm its status
ClamartFranceRecruiting
Centre Hospitalier Universitaire de Clermont-Ferrand - Hôpital Gabriel Montpied
Coordinator of this site? Confirm its status
Clermont-Ferrand Cedex 1FranceRecruiting
Centre Hospitalier Universitaire de Dijon
Coordinator of this site? Confirm its status
DijonFranceRecruiting
CHU De Martinique
Coordinator of this site? Confirm its status
Fort De France CedexFranceRecruiting
Hôpital Raymond-Poincaré
Coordinator of this site? Confirm its status
GarchesFranceRecruiting
Centre Hospitalier Departemental Vendee
Coordinator of this site? Confirm its status
La Roche Sur Yon Cedex 9FranceRecruiting
Centre Hospitalier Et Universitaire de Limoges
Coordinator of this site? Confirm its status
LimogesFranceRecruiting
Centre Hospitalier Regional De Marseille
Coordinator of this site? Confirm its status
MarseilleFranceRecruiting
Centre Hospitalier Universitaire De Montpellier
Coordinator of this site? Confirm its status
Montpellier Cedex 5FranceRecruiting
Centre Hospitalier Universitaire de Nantes
Coordinator of this site? Confirm its status
NantesFranceRecruiting
Centre Hospitalier Universitaire de Nice
Coordinator of this site? Confirm its status
NiceFranceRecruiting
Centre Hospitalier Universitaire D Orleans
Coordinator of this site? Confirm its status
Orleans Cedex 2FranceRecruiting
Centre Hospitalier Universitaire Hôtel-Dieu
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Hôpital Bichat - Claude-Bernard
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Hôpital Lariboisière APHP
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Hopital Necker Enfants Malades
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Hopital Saint Louis
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Hopital Saint Antoine
Coordinator of this site? Confirm its status
Paris Cedex 12FranceRecruiting
Hopitaux Universitaires Pitie Salpetriere
Coordinator of this site? Confirm its status
Paris Cedex 13FranceRecruiting
Hopital Tenon
Coordinator of this site? Confirm its status
Paris Cedex 20FranceRecruiting
Centre Hospitalier Universitaire de la Guadeloupe
Coordinator of this site? Confirm its status
Pointe-à-Pitre CedexFranceRecruiting
Centre Hospitalier Intercommunal De Cornouaille
Coordinator of this site? Confirm its status
Quimper CedexFranceRecruiting
Centre Hospitalier Universitaire Reims
Coordinator of this site? Confirm its status
Reims CedexFranceRecruiting
Centre Hospitalier Universitaire de Rennes
Coordinator of this site? Confirm its status
RennesFranceRecruiting
Centre Hospitalier Universitaire de Saint Etienne
Coordinator of this site? Confirm its status
Saint-Priest-en-JarezFranceRecruiting
Centre Hospitalier General De St Denis
Coordinator of this site? Confirm its status
St Denis CedexFranceRecruiting
Nouvel Hopital Civil Strasbourg
Coordinator of this site? Confirm its status
StrasbourgFranceRecruiting
Centre Hospitalier Universitaire de Toulouse
Coordinator of this site? Confirm its status
ToulouseFranceRecruiting
Centre Hospitalier De Tourcoing
Coordinator of this site? Confirm its status
Tourcoing CedexFranceRecruiting
Centre Hospitalier Intercommunal de Villeneuve Saint Georges
Coordinator of this site? Confirm its status
Villeneuve-Saint-GeorgesFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.