Valganciclovir or Ganciclovir for Congenital CMV Disease
CMV CTLs in Neonates With CMV Infection
Recruiting
Phase 2
Interventional Study
Congenital Cytomegaloviral (CMV) Disease
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
- 0 Days – 21 Days
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 23 (estimated)
- Sponsor
- New York Medical College · Other
Who this trial is looking for
This trial is looking for newborns with moderate or severe congenital CMV disease who are less than 21 days old. Participants will receive treatment with antiviral medications and may also receive an additional treatment with CMV CTLs if found safe.
Are You a Good Fit for This Trial?
You may be able to join if
- I am less than 21 days old
- I weigh at least 2500 grams at birth
- I was born at 34 weeks or later
- I have been diagnosed with CMV infection
- I have moderate or severe CMV disease
- My mother is a suitable donor with a specific immune response
You may not be able to join if
- I am receiving steroids on the same day of treatment
- I am part of another clinical trial for CMV treatment
- I have a medical condition that affects my participation
- My mother has a known history of HIV infection
- My representative cannot give informed consent
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.
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About This Trial
Patients with moderate or severe CMV disease less than 21 days old who have a maternal donor who has a CMV response to the peptivators will be screened.
All patients will receive treatment with valganciclovir or ganciclovir. There is a safety run in with treatment with CMV CTLs in cohort 1 and if found to be safe, will proceed to cohort 2 for randomization to receive antiviral therapy with or wit…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age: ≤ 21 days of life
* Birth Weight: ≥ 2500 gms
* Gestational age: ≥ 34 weeks of age
* Diagnosis of CMV viremia, viruria, and/or infection:Either one or more:
Elevated CMV by RT-PCR in urine, saliva, CSF, or plasma; and/or Positive urine culture for CMV
\- Moderate or Seve…
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