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Neonatal Phase 1 Valacyclovir Study

Valacyclovir trial for newborns. Participation is voluntary.

Recruiting
1-2 years
All
Phase 1

This is a study to find out the right dose of a medicine called valacyclovir for newborns who might get a virus called neonatal herpes simplex virus (HSV). Valacyclovir is a medicine that turns into acyclovir in the body, which can fight the virus. The study will have two groups of babies. In the first group, eight babies will take the medicine. Doctors will check if the medicine is safe and how much of it reaches the baby's body. If all goes well, a second group of eight babies will join, and they might get a different dose based on what was learned from the first group. Babies can join if their moms had a history of HSV and took valacyclovir before birth. This study helps find a safe and effective dose for babies.

  • The study involves two groups of eight newborns each.
  • Participation involves taking valacyclovir and monitoring at home.
  • Babies must meet specific health criteria to join the study.
Study details
    Herpes Simplex

NCT05468619

National Institute of Allergy and Infectious Diseases (NIAID)

15 March 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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