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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
Must not have
Known renal anomalies or dysfunction
Current receipt in the neonate of acyclovir, ganciclovir, famciclovir, or any investigational drugs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1 - 42
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have known kidney issues.
Select...
My newborn is currently receiving treatment with acyclovir, ganciclovir, famciclovir, or any experimental drugs.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acyclovir
Secondary study objectives
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%
Tremor
8%
Chest pain
8%
Blood creatinine increased
8%
Syncope
8%
Pyrexia
5%
Hallucinaion
5%
Reticulocyte count abnormal
5%
Ageusia
5%
Dysgeusia
5%
Irritability
5%
Paraesthesia
5%
White blood cells urine positive
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%
Cerebral infarction
3%
Loss of consciousness
3%
Neck pain
3%
Nervousness
3%
Salivary hypersecretion
3%
Meralgia paraesthetica
3%
Oedema peripheral
3%
Blood uric acid abnormal
3%
Brain abscess
3%
Cerebrovascular accident
3%
Coagulopathy
3%
Creatinine renal clearance decreased
3%
Neutrophil count abnormal
3%
Retinal ischaemia
3%
Blood urea
3%
Blood uric acid decreased
3%
Urine analysis abnormal
3%
Nightmares
3%
Stress
3%
Pulmonary embolism
3%
Papillary thyroid cancer
3%
Renal failure acute
3%
Agitation
3%
Agitated depression
3%
Asthenia
3%
Amnesia
3%
Billiary dyskinesia
3%
Blood glucose increased
3%
Confusional state
3%
Depressed level of consciousness
3%
Diverticulitis
3%
Dysaesthesia
3%
Gingival hyperplasia
3%
Haemoglobin decreased
3%
Herpes zoster
3%
Panic attack
3%
Urosepsis
3%
Weight increased
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
3,323 Previous Clinical Trials
5,365,158 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
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