Doravirine/Lamivudine vs Dolutegravir/Lamivudine for HIV
Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Successfully
Recruiting
Phase 2
Interventional Study
HIV-1-infection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 408 (estimated)
- Sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida · Other
Who this trial is looking for
This trial is looking for adults living with HIV who have been stable on their treatment. Participants will compare two different treatment options to see which works better for maintaining low levels of HIV in the blood.
Are You a Good Fit for This Trial?
You may be able to join if
- I am at least 18 years old.
- I live with HIV-1.
- My HIV viral load has been below 50 copies/mL for at least 24 months.
- I have been on a stable three-drug treatment for at least 12 months.
- I am affiliated with French Social Insurance.
- I have agreed to participate in the study.
You may not be able to join if
- I have HIV-2.
- I have been co-infected with hepatitis B.
- I have documented resistance mutations to the study drugs.
- My kidney function is below 50 mL/min.
- I take medications that interact with the study drugs.
- I am pregnant or breastfeeding.
- I have a medical condition that limits my ability to join a study.
- I am under legal guardianship or judicial protection.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 cop…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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…
Contacts