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Taking people in PolandPhase 2

Different valacyclovir doses for a first cytomegalovirus infection in pregnancy

Compares valacyclovir doses in pregnant women with a first cytomegalovirus infection.

Key facts

Who runs it
Instytut Matki I Dziecka
Where
Olsztyn and Warsaw, PolandSee the 2 sites
Registry title
Clinical trial (study) comparing the efficacy and safety of valacyclovir used in the prevention and treatment of primary cytomegalovirus (CMV) infection in pregnant women depending on the used drug dose.
Status
Recruiting
Phase
Phase 2
People taking part
200 people, planned
Started
2 Aug 2024
Expected to end
30 Jun 2027
Type of study
Interventional
Record updated
10 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for pregnant women with a first (primary) CMV infection during this pregnancy. It compares doses of valacyclovir to prevent passing the infection to the baby and to treat it.

Age
18 years and older (record lists 18 Years to 64 Years).
Sex
Women only (pregnant).
Disease stage
Primary CMV infection found before 16 weeks of pregnancy. Pregnancy with one baby or twins.
Earlier treatment
Cannot have taken part in another clinical trial in the 3 months before joining.
Biomarker or test result
CMV IgG antibodies that were negative earlier in this pregnancy and are now positive, and/or CMV IgM and IgG antibodies with low avidity (below 50% or marked low by the lab).

Main reasons for not taking part

  • Allergy or hypersensitivity to valacyclovir or acyclovir
  • Kidney disease, abnormal liver tests or other chronic diseases
  • Positive routine tests for HBV, HIV, HCV, active or recent toxoplasma infection, or positive WR test
  • Not vaccinated against tuberculosis, or unable to have an MRI scan
  • Mental disorder or intellectual disability; more than twins

This trial only enrols pregnant participants. The registry sentence this rests on: Pregnant women aged 18 years and older.

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • Pregnant women aged 18 years and older
  • The presence of IgG antibodies to CMV, whose previous result in the current pregnancy was negative (seroconversion) and/or antibodies to CMV in the IgM and IgG classes with low avidity (below 50% or index marked by the laboratory as low avidity)
  • The presence of the above-mentioned antibodies before 16 weeks of pregnancy
  • Giving written informed consent to participate in the study
  • Confirmed singleton or twin pregnancy

Who cannot take part

  • A patient who participated in any other clinical trial 3 months before enrollment in the study
  • Known allergy or hypersensitivity to valacyclovir or acyclovir
  • Mental disorder or intellectual disability
  • Renal disease, abnormal liver function parameters, chronic diseases
  • Positive result of screening tests for viral diseases performed routinely in accordance with the standard of perinatal care (HBV, HIV, HCV), active/recent TOXO infection, WR
  • Patients not vaccinated against tuberculosis
  • Pregnant women aged under 18
  • Contraindications to magnetic resonance imaging
  • Multiple pregnancy (more than twins)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 64 years old?

Where in Poland

  • Wojewódzki Szpital Specjalistyczny w OlsztynieOlsztyn, PolandTaking people
  • Instytut Matki i DzieckaWarsaw, PolandTaking people

About the trial

What the trial wants to find out

The aim of the study is to compare the efficacy and safety of valacyclovir in the prevention of transmission and treatment of intrauterine infection in pregnant women with primary CMV infection in a dose-dependent manner.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Comparison of the efficacy and safety of valaciclovir in the prevention of transmission and treatment of intrauterine infection in pregnant women with primary cytomegalovirus infection depending on the used drug dose - the first Polish non-commercial non-inferiority clinical trial.
Plain-language title
Different valacyclovir doses for a first cytomegalovirus infection in pregnancyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from 2023-508643-46-00, who can take part
Record updated
10 March 2026