Actively Recruiting
Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-01-02
80
Participants Needed
5
Research Sites
167 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
U
URC-CIC Paris Descartes Necker Cochin
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and the tolerance of letermovir as part of dual antiviral therapy (in association with valganciclovir) in renal transplant recipients with CMV DNAemia, requiring valganciclovir treatment per investigator's judgment.
CONDITIONS
Official Title
Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Weight 30 kg or more
- Kidney transplant recipient
- Documented CMV infection or disease with specific CMV DNA levels in blood as measured by lab tests
- Eligible for oral valganciclovir treatment as judged by investigator
- For women of childbearing age: negative pregnancy test and use of effective contraception until 30 days after exposure
- For men: use of effective contraception until 90 days after exposure
- Life expectancy of at least 8 weeks
- French speaking
- Affiliated with social security or equivalent
- Signed informed consent
You will not qualify if you...
- Current CMV infection that is refractory or resistant due to poor antiviral adherence
- CMV infection known to be resistant to valganciclovir or letermovir
- Treated with anti-CMV agents for current infection for more than 72 hours (except prophylaxis cases)
- Severe kidney impairment with eGFR below 15 mL/min/1.73m2
- Liver enzyme levels 5 times above normal or bilirubin 3 times above normal (except Gilbert's syndrome)
- Severe chronic liver disease (Child-Pugh Class C)
- HIV infection with plasma HIV RNA 50 copies/mL or more in last 3 months
- Need for mechanical ventilation or vasopressors
- Pregnant or breastfeeding
- Received anti-CMV vaccine previously
- Taking leflunomide or artesunate at treatment start
- Taking strong CYP enzyme inhibitors or inducers at treatment start
- Taking specific listed medications at treatment start
- Known hereditary intolerance to galactose or related metabolic disorders
- Hypersensitivity to letermovir or study medication components
- Medical or surgical conditions that interfere with study or pose safety risks
- Participation in another clinical drug trial
- Very low blood cell counts (neutrophils, platelets, hemoglobin)
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Hôpital Necker Enfants Malades
Paris, France, 75015
Actively Recruiting
2
Hôpital de la Pitié Salpêtrière, Service de Néphrologie
Paris, Île-de-France Region, France, 75013
Actively Recruiting
3
Hôpital Européen Georges Pompidou
Paris, Île-de-France Region, France, 75015
Actively Recruiting
4
Hôpital Necker Enfants Malades - SMIT
Paris, Île-de-France Region, France, 75015
Actively Recruiting
5
Centre 011-Hôpital Bichat, Service de Néphrologie
Paris, Île-de-France Region, France, 75018
Actively Recruiting
Research Team
P
Pierre FRANGE, MD, PhD
CONTACT
A
Aminata TRAORE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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