Taking people in FrancePhase 3
Tests two-drug HIV maintenance treatments in adults with suppressed virus
Compares doravirine/lamivudine with dolutegravir/lamivudine in adults with HIV.
Key facts
- Who runs it
- Centre De Recherches Et D'Etudes Sur La Pathologie Tropicale Et Le Sida
- Where
- Angers, Argenteuil Cedex, Bobigny, Bordeaux, Bordeaux Cedex, Boulogne-Billancourt, Clamart, Clermont-Ferrand Cedex 1, Dijon, Fort De France Cedex, Garches, La Roche Sur Yon Cedex 9, Limoges, Marseille, Montpellier Cedex 5, Nantes, Nice, Orleans Cedex 2, Paris, Paris Cedex 12, Paris Cedex 13, Paris Cedex 20, Pointe-à-Pitre Cedex, Quimper Cedex, Reims Cedex, Rennes, Saint-Priest-en-Jarez, St Denis Cedex, Strasbourg, Toulouse, Tourcoing Cedex, and Villeneuve-Saint-Georges, FranceSee the 36 sites
- Trial code
- Registry title
- MODULO
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 408 people, planned
- Started
- 30 Apr 2025
- Expected to end
- 1 Jun 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Record updated
- 16 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults living with HIV-1 whose virus has been undetectable for at least 24 months on a three-drug regimen. It compares two two-drug regimens.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- HIV-1 with viral load below 50 copies/mL for at least 24 months
- Earlier treatment
- Stable three-drug regimen (2 NRTIs plus 1 NNRTI, 1 INSTI or 1 boosted PI) for at least 6 months
- Biomarker or test result
- At least one resistance genotype is required; the virus must be fully sensitive to doravirine, dolutegravir and lamivudine. No documented resistance mutations to these drugs.
Main reasons for not taking part
- HIV-2 co-infection
- Hepatitis B virus co-infection
- Kidney filtration rate below 50 mL/min
- Medicines that interact with one of the 3 study drugs
- Pregnant or breastfeeding women, or women able to become pregnant who refuse contraception
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- Comedications leading to drug-drug interaction with one of the 3 study drugs (cf. detailed protocol)
- 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
- Pregnant or breastfeeding women, and women with age to be pregnant but refusing contraception
- 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)
Where in France
- Centre Hospitalier Universitaire D'AngersAngers, FranceTaking people
- Centre Hospitalier Victor DupouyArgenteuil Cedex, FranceTaking people
- Hopital AvicenneBobigny, FranceTaking people
- Centre hospitalier Universitaire de BordeauxBordeaux, FranceTaking people
- Centre Hospitalier Universitaire De BordeauxBordeaux Cedex, FranceTaking people
- Hôpital Ambroise-ParéBoulogne-Billancourt, FranceTaking people
- Hopital Antoine BeclereClamart, FranceTaking people
- Centre Hospitalier Universitaire de Clermont-Ferrand - Hôpital Gabriel MontpiedClermont-Ferrand Cedex 1, FranceTaking people
- Centre Hospitalier Universitaire de DijonDijon, FranceTaking people
- CHU De MartiniqueFort De France Cedex, FranceTaking people
- Hôpital Raymond-PoincaréGarches, FranceTaking people
- Centre Hospitalier Departemental VendeeLa Roche Sur Yon Cedex 9, FranceTaking people
- Centre Hospitalier Et Universitaire de LimogesLimoges, FranceTaking people
- Centre Hospitalier Regional De MarseilleMarseille, FranceTaking people
- Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranceTaking people
- Centre Hospitalier Universitaire de NantesNantes, FranceTaking people
- Centre Hospitalier Universitaire de NiceNice, FranceTaking people
- Centre Hospitalier Universitaire D OrleansOrleans Cedex 2, FranceTaking people
- Centre Hospitalier Universitaire Hôtel-DieuParis, FranceTaking people
- Hôpital Bichat - Claude-BernardParis, FranceTaking people
- Hôpital Lariboisière APHPParis, FranceTaking people
- Hopital Necker Enfants MaladesParis, FranceTaking people
- Hopital Saint LouisParis, FranceTaking people
- Hopital Saint AntoineParis Cedex 12, FranceTaking people
- Hopitaux Universitaires Pitie SalpetriereParis Cedex 13, FranceTaking people
- Hopital TenonParis Cedex 20, FranceTaking people
- Centre Hospitalier Universitaire de la GuadeloupePointe-à-Pitre Cedex, FranceTaking people
- Centre Hospitalier Intercommunal De CornouailleQuimper Cedex, FranceTaking people
- Centre Hospitalier Universitaire ReimsReims Cedex, FranceTaking people
- Centre Hospitalier Universitaire de RennesRennes, FranceTaking people
- Centre Hospitalier Universitaire de Saint EtienneSaint-Priest-en-Jarez, FranceTaking people
- Centre Hospitalier General De St DenisSt Denis Cedex, FranceTaking people
- Nouvel Hopital Civil StrasbourgStrasbourg, FranceTaking people
- Centre Hospitalier Universitaire de ToulouseToulouse, FranceTaking people
- Centre Hospitalier De TourcoingTourcoing Cedex, FranceTaking people
- Centre Hospitalier Intercommunal de Villeneuve Saint GeorgesVilleneuve-Saint-Georges, FranceTaking people
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- DORAVIRINE/LAMIVUDINE combinationTreatment being tested
Patients randomized to "arm 1" will receive the DORAVIRINE/LAMIVUDINE combination: doravirin (PIFELTRO®) 100 mg 1 tablet per day + lamivudine (generic) 300 mg 1 tablet per day The dosage is in accordance with the summary of product characteristics of each product.
Treatment: Doravirine 100Mg Tab and Lamivudine 300 Mg Tab
- Fixed DOLUTEGRAVIR/LAMIVUDINE combinationExisting treatment, for comparison
Patients randomized to arm 2 will receive the fixed combination DOLUTEGRAVIR/LAMIVUDINE: dolutegravir 50 mg/lamivudine 300 mg (DOVATO®) 1 tablet per day. The dosage is in accordance with the summary of product characteristics of each product.
Treatment: Dolutegravir 50mg Tab and Lamivudine 300 Mg Tab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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
- Plain-language title
- Tests two-drug HIV maintenance treatments in adults with suppressed virusGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 16 July 2026