Actively Recruiting
Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Successfully
Led by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida · Updated on 2025-06-11
408
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
Sponsors
C
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Lead Sponsor
A
ANRS, Emerging Infectious Diseases
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Successfully
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Living with HIV-1 infection
- Plasma viral load below 50 copies/mL for at least 24 months
- Stable three-drug antiretroviral regimen including 2 NRTIs plus 1 NNRTI or 1 INSTI or 1 boosted PI for at least 12 months
- Affiliated to the French Social Insurance
- Provided written consent to participate in the study
You will not qualify if you...
- 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 mutations causing partial or full resistance to doravirine, dolutegravir, or lamivudine
- No available resistance genotype as required before inclusion
- Glomerular filtration rate below 50 mL/min (CKD-EPI formula)
- Use of comedications that interact with study drugs
- Pregnant or breastfeeding women, or women of childbearing potential not using effective contraception
- Immunocompromised conditions including active cancer, hematological malignancy, recent organ transplant/rejection, immunosuppressive therapy, or other conditions impairing immunity
- Persons under legal guardianship or judicial protection due to limited mental or physical faculties
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hôpital Pitié-Salpêtrière
Paris, Île-de-France Region, France, 75013
Actively Recruiting
Research Team
Y
Yasmine DUDOIT
CONTACT
R
Romain PALICH, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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