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Anti-viral
Valacyclovir for Neonatal Herpes
Phase 1
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Weight at study enrollment = 2,000 grams
Gestational age = 38 weeks at birth
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1 - 42
Awards & highlights
Study Summary
This trial is testing a new dose of valacyclovir for preventing neonatal herpes simplex virus (HSV). The initial dose will be 10ml/kg, and if it's safe and effective, eight more subjects will be enrolled at a higher dose.
Who is the study for?
This trial is for newborns at risk of herpes who are born to mothers with a history of genital HSV infection. The babies must be full-term, weigh at least 2,000 grams, and be no older than 2 days. They can't participate if they have signs of herpes or sepsis, known kidney issues, or were born to HIV-positive mothers.Check my eligibility
What is being tested?
The study tests oral Valacyclovir in two groups (cohorts) of eight newborns each to find the right dose that matches the effect of an existing treatment for herpes. The second group's dose will depend on results from the first group.See study design
What are the potential side effects?
While specific side effects in neonates aren't listed here, common ones in adults include headache, nausea and potential kidney problems which might also occur in infants.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My weight is at least 2,000 grams at the time of joining the study.
Select...
My baby was born at or after 38 weeks of pregnancy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1 - 42
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1 - 42
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acyclovir
Secondary outcome measures
Half-life (t1/2) of acyclovir
Acyclovir
Occurrence of Grade 3 Adverse Events (AEs)
+4 moreSide effects data
From 2011 Phase 3 trial • 91 Patients • NCT0003148640%
Nausea
30%
Headache
18%
Urinary tract infection
18%
Depression
15%
Fatigue
13%
Insomnia
13%
Anxiety
10%
Constipation
10%
Vomiting
10%
Dyspepsia
10%
Weight decreased
10%
Hypoaesthesia
8%
Chest pain
8%
Tremor
8%
Blood creatinine increased
8%
Syncope
8%
Pyrexia
5%
Paraesthesia
5%
Ageusia
5%
Dysgeusia
5%
Hallucinaion
5%
Irritability
5%
White blood cells urine positive
5%
Reticulocyte count abnormal
5%
Parosmia
5%
Back pain
5%
Dizziness
5%
Encephalitis herpes
5%
Muscular weakness
5%
Convulsion
5%
Alanine aminotransferase increased
5%
Arthralgia
5%
Candidiasis
5%
Hyperreflexia
3%
Nightmares
3%
Salivary hypersecretion
3%
Papillary thyroid cancer
3%
Retinal ischaemia
3%
Stress
3%
Panic attack
3%
Loss of consciousness
3%
Brain abscess
3%
Cerebrovascular accident
3%
Agitated depression
3%
Amnesia
3%
Asthenia
3%
Gingival hyperplasia
3%
Blood glucose increased
3%
Billiary dyskinesia
3%
Pulmonary embolism
3%
Agitation
3%
Blood urea
3%
Blood uric acid abnormal
3%
Diverticulitis
3%
Blood uric acid decreased
3%
Haemoglobin decreased
3%
Meralgia paraesthetica
3%
Cerebral infarction
3%
Dysaesthesia
3%
Nervousness
3%
Weight increased
3%
Coagulopathy
3%
Neck pain
3%
Creatinine renal clearance decreased
3%
Renal failure acute
3%
Confusional state
3%
Depressed level of consciousness
3%
Herpes zoster
3%
Neutrophil count abnormal
3%
Urosepsis
3%
Oedema peripheral
3%
Urine analysis abnormal
3%
Osteoarthritis
3%
Abdominal pain
3%
Pharyngitis
3%
Vulvovaginal mycotic infection
3%
Suicide attempt
3%
Aphthous stomatitis
3%
Diarrhoea
3%
Dysphagia
3%
Embolism
3%
Encephalitis
3%
Fall
3%
Wound infection
3%
Abdominal discomfort
3%
Abdominal distension
3%
Abdominal pain upper
3%
Blood alkaline phosphatase increased
3%
Blood creatinine abnormal
3%
Blood glucose abnormal
3%
Eosinophil count abnormal
3%
Feeling cold
3%
Gingivitis
3%
Global anmesia
3%
Haematocrit abnormal
3%
Haemoglobin abnormal
3%
Haemorrhage intracranial
3%
Musculoskeletal discomfort
3%
Musculoskeletal disorder
3%
Pharyngitis streptococcal
3%
Sialoadenitis
3%
Tooth loss
3%
Upper respiratory tract infection
3%
Dry mouth
3%
Alanine aminotransferase abnormal
3%
Anosmia
3%
Migraine
3%
Nystagmus
3%
Radial nerve palsy
3%
Red blood cell count abnormal
3%
Lymphadenectomy
3%
Hyperaesthesia
3%
Hypertonia
3%
Hypomania
3%
Influenza
3%
Obsessive-compulsive disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Valacyclovir
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
If the safety profile and the drug exposure concentrations in Cohort 1 are acceptable, eight new subjects will be enrolled in Cohort 2. If the mean of observed acyclovir exposures of subjects in Cohort 1 are below 24,000 ngxhr/mL, AND if no Grade 3 or Grade 4 AEs or SAEs are detected in any of the study subjects, then the 8 subjects enrolled in Cohort 2 will receive oral valacyclovir at a dose of 20 mg/kg administered two times daily for 5 days. Alternatively, if the mean of observed acyclovir exposures of subjects in Cohort 1 are above 48,000 ngxhr/mL AND if no Grade 3 or Grade 4 AEs or SAEs are detected in any of the study subjects, then the 8 subjects enrolled in Cohort 2 will receive oral valacyclovir at a dose that has been linearly adjusted downward to target 36,000 ngxh/mL area-under-the-concentration-time curve from 0 to 12 hours (AUC12).
Group II: Cohort 1Experimental Treatment1 Intervention
A cohort of neonates who are at risk of acquiring neonatal herpes simplex virus disease will receive 10 mg/kg of valacyclovir will be administered orally two times daily for 5 days. N=8
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valacyclovir
2008
Completed Phase 4
~2520
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,453 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at least 2 days old.Your mother has a history of genital herpes.There is proof that the baby has a herpes infection.I have known kidney issues.My baby was born at or after 38 weeks of pregnancy.My weight is at least 2,000 grams at the time of joining the study.My newborn is currently receiving treatment with acyclovir, ganciclovir, famciclovir, or any experimental drugs.I took antiviral medication for at least 7 days before giving birth.The mother has genital sores that look like they could be caused by herpes at the time of giving birth.Babies born to mothers with HIV, even if the baby's HIV status is not tested.You have signs of a severe infection in your body.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
Herpes Patient Testimony for trial: Trial Name: NCT05468619 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is capable of meeting the prerequisites for this research trial?
"This clinical trial is enrolling 16 infants between 1 and 2 days old that have been diagnosed with herpes simplex. In addition to this, they must meet other criteria such as: maternal history of HSV infection, the mother has taken oral antivirals in the last 7 days before birth, gestational age at delivery was 38 weeks or higher, weight is equal to or greater than 2000 grams when enrolled and signed informed consent from parent(s) or legal guardian(s)."
Answered by AI
Does this clinical trial still accept new participants?
"The post on clinicaltrials.gov reveals that this trial is no longer recruitment participants, as the date of its last update was September 29th 2022. Although patients can not join in this specific study, 28 other trials are actively enrolling individuals at present."
Answered by AI
Has the US Food & Drug Administration marked Valacyclovir as safe and effective?
"This experimental drug has yet to be thoroughly tested, so it garnered a safety rating of 1. As this is only the initial phase (1) of clinical trials for Valacyclovir, there is limited evidence demonstrating its benefit and efficacy in humans."
Answered by AI
To what extent is this experimental endeavor being conducted?
"To date, 12 medical facilities have been enlisted for this clinical trial. Among them are Atrium Health ID Consultants & Infusion Care Specialists in Charlotte, Ohio State University - Wexner Medical Center - Infectious Diseases Clinic in Columbus and Emory Children's Centre- Pediatric Infectious Diseases in Atlanta. Additionally, there are 9 other locations enrolled across the country."
Answered by AI
Can those aged 45 and under join in this research?
"This clinical trial's eligibility criteria specifies that potential recruits must be aged between one day and two days old. Additionally, there are 6 studies for minors and 23 for elderly applicants."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
New York
Other
Texas
How old are they?
18 - 65
What site did they apply to?
University of Louisville School of Medicine - Norton Children's Hospital - Infectious Diseases
University of Nebraska Medical Center - Children's Hospital and Medical Center - Infectious Diseases
Steven and Alexandra Cohen Childrens Medical Center of New York - New Hyde Park - Infectious Disease
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2
0
What questions have other patients asked about this trial?
Why did patients apply to this trial?
Like to be cured. I’m looking to get rid of this disease. I have tried using a couple different medications. I am a US Army ardmyw.
PatientReceived no prior treatments
Anti viral drugs don’t work for my HSV 2. I have 10 plus outbreaks a year and most of them are bad outbreaks.
PatientReceived no prior treatments
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