Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Successfully
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
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
408 participants
Apr 30, 2025
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria6
- Adults ≥18 years;
- Living with HIV-1;
- With pVL <50 copies/mL for at least 24 months;
- Under stable three-drug regimen including 2 NRTIs + 1 NNRTI or 1 INSTI or 1 boosted PI for at least 12 months;
- Affiliated to the French Social Insurance;
- Who have given their written consent to participate in the study
Exclusion Criteria17
- HIV-2 co-infection;
- Co-infection with hepatitis B virus (positive HBsAg and/or positive anti-HBc antibody with negative anti-HBs antibody);
- Documented resistance mutation or association of resistance mutations, associated with partial or full resistance to doravirine, dolutegravir or lamivudine;
- At least one resistance genotype is mandatory to include the patient:
- 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,
- 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,
- Past virological failure is defined as: 2 consecutive pVL ≥50 copies/mL or one pVL ≥200 copies/mL,
- Resistance genotypes will be interpretated with the last available ANRS algorithm.
- Glomerular filtration rate <50 mL/min (CKD-EPI formula);
- Comedications leading to drug-drug interaction with one of the 3 study drugs (cf. detailed protocol);
- Pregnant or breastfeeding women, and women with age to be pregnant but refusing effective contraception, whether or not a desire for pregnancy is expressed;
- Any clinal condition limiting the participation in a clinical trial: Immunocompromised conditions including active cancer or hematological malignancy, organ transplant or with transplant rejection within the last 6 months, immunosuppressive therapy, or other condition that in the opinion of the investigator could cause impaired host immunity
- Protected adults (persons under legal guardianship or under "sauvegarde de justice" (judicial protection due to temporarily and slightly diminished mental or physical faculties)
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Interventions
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
Participants randomised in the "arm 2" will receive the DTG/3TC combination: dolutegravir 50 mg/lamivudine 300 mg (DOVATO®) 1 pill a day
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06774872