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
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire D'Angers Coordinator of this site? Confirm its status | Angers | France | Recruiting |
| Centre Hospitalier Victor Dupouy Coordinator of this site? Confirm its status | Argenteuil Cedex | France | Recruiting |
| Hopital Avicenne Coordinator of this site? Confirm its status | Bobigny | France | Recruiting |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Hospitalier Universitaire De Bordeaux Coordinator of this site? Confirm its status | Bordeaux Cedex | France | Recruiting |
| Hôpital Ambroise-Paré Coordinator of this site? Confirm its status | Boulogne-Billancourt | France | Recruiting |
| Hopital Antoine Beclere Coordinator of this site? Confirm its status | Clamart | France | Recruiting |
| Centre Hospitalier Universitaire de Clermont-Ferrand - Hôpital Gabriel Montpied Coordinator of this site? Confirm its status | Clermont-Ferrand Cedex 1 | France | Recruiting |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| CHU De Martinique Coordinator of this site? Confirm its status | Fort De France Cedex | France | Recruiting |
| Hôpital Raymond-Poincaré Coordinator of this site? Confirm its status | Garches | France | Recruiting |
| Centre Hospitalier Departemental Vendee Coordinator of this site? Confirm its status | La Roche Sur Yon Cedex 9 | France | Recruiting |
| Centre Hospitalier Et Universitaire de Limoges Coordinator of this site? Confirm its status | Limoges | France | Recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Centre Hospitalier Universitaire D Orleans Coordinator of this site? Confirm its status | Orleans Cedex 2 | France | Recruiting |
| Centre Hospitalier Universitaire Hôtel-Dieu Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hôpital Bichat - Claude-Bernard Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hôpital Lariboisière APHP Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hopital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hopital Saint Antoine Coordinator of this site? Confirm its status | Paris Cedex 12 | France | Recruiting |
| Hopitaux Universitaires Pitie Salpetriere Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Recruiting |
| Hopital Tenon Coordinator of this site? Confirm its status | Paris Cedex 20 | France | Recruiting |
| Centre Hospitalier Universitaire de la Guadeloupe Coordinator of this site? Confirm its status | Pointe-à-Pitre Cedex | France | Recruiting |
| Centre Hospitalier Intercommunal De Cornouaille Coordinator of this site? Confirm its status | Quimper Cedex | France | Recruiting |
| Centre Hospitalier Universitaire Reims Coordinator of this site? Confirm its status | Reims Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Recruiting |
| Centre Hospitalier General De St Denis Coordinator of this site? Confirm its status | St Denis Cedex | France | Recruiting |
| Nouvel Hopital Civil Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Centre Hospitalier De Tourcoing Coordinator of this site? Confirm its status | Tourcoing Cedex | France | Recruiting |
| Centre Hospitalier Intercommunal de Villeneuve Saint Georges Coordinator of this site? Confirm its status | Villeneuve-Saint-Georges | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.