Tests two-drug HIV maintenance treatments in adults with suppressed virus

Trial details

Who runs it

Centre De Recherches Et D'Etudes Sur La Pathologie Tropicale Et Le Sida

Trial code

NCT06774872EU 2024-515793-27-01

Record updated

16 July 2026

Original description

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).Read full original descriptionShow less

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

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).

Inclusion: 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.

Exclusion: 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).

ClinicalTrials.gov NCT06774872 · EU CTIS 2024-515793-27-01