Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Successfully
Recruiting now · Phase 2
Conditions studied: HIV-1-infection
In brief
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).
Key facts
- Study ID
- NCT06774872
- Run by
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
- People needed
- 408
- Starts
- 2025-04-30
- Expected to finish
- 2028-06-15
- Last updated by the study team
- 2025-06-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Hôpital Pitié-Salpêtrière — Paris, Île-de-France Region, France (enrolling)
Full record on ClinicalTrials.gov
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