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Valacyclovir for Neonatal Herpes
Study Summary
This trial will study the effects of the antiviral drug valacyclovir in newborns with HSV disease, comparing it to the standard of care treatment with acyclovir.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2011 Phase 3 trial • 91 Patients • NCT00031486Trial Design
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- I started acyclovir treatment when I was 42 days old or younger.Your creatinine level in the blood is less than 1.2.I am on a short-term acyclovir treatment prescribed by my doctor.You are expected to pass away soon.You have a serious birth defect that could affect how your body processes the study drug.Your creatinine level is higher than 1.2 before starting valacyclovir.You have a weakened immune system, such as from HIV or immune deficiencies.My HSV infection has been confirmed by a lab test.I started acyclovir treatment when I was older than 42 days.I was born after 34 weeks of pregnancy.My weight is at least 2000 grams at the time of joining the study.
- Group 1: Neonatal HSV disease requiring suppressive therapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is my profile suitable for enrollment into this medical experiment?
"Candidates between 2 and 12 weeks old with a diagnosis of herpes simplex are eligible to take part in this study, which is currently recruiting around 10 participants."
Does this clinical trial represent a pioneering endeavor?
"Presently, 11 active trials for this medication are being conducted in 121 cities across four countries. Going back to 2006 when Millennium Pharmaceuticals Inc first tested the drug with 46 patients, 64 studies have been completed so far."
Are there any other research initiatives focusing on this particular therapy?
"At present, 11 clinical studies are ongoing and attempting to gauge the efficacy of this treatment with 1 trial having reached Phase 3. While Houston, Texas has multiple trials for this medication, 199 other sites across the world have begun their own investigations as well."
Are elderly people above 85 eligible for this investigation?
"According to the listed qualifications, participants must lie within 2-12 Weeks of age."
How does the risk-benefit ratio of this treatment measure up for individuals?
"Our internal assessment at Power concluded that this intervention's safety rating should be a 1, as Phase 1 trials provide scant evidence of efficacy and security."
To what extent is participation being sought in this research project?
"Affirmative. The information hosted on clinicaltrials.gov confirms that this research study, which was initially published on July 1st 2021, is recruiting patients at present. Specifically, 10 people who fit the criteria need to be enrolled from one location."
Are recruitments ongoing for this research endeavor?
"Affirmative. Clinicaltrials.gov records suggest that this clinical trial has reopened recruitment, which began on July 1st 2021 and was last updated in September 12th 2022. Currently, the study requires 10 participants from a single medical centre."
What medical conditions is this therapy commonly prescribed for?
"This therapeutic intervention is typically used to manage genital herpes but can also successfully address conditions such as HIV-1, labialis herpetic infection, and varicella."
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