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Anti-viral

Valacyclovir for Neonatal Herpes

Phase 1
Recruiting
Led By Richard Whitley, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≤ 42 days of age at initiation of parenteral acyclovir
Receiving intravenous acyclovir, prescribed by the patient's physician for ≤ 14 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one pk level drawn randomly on days 1-7; in addition, on one day between day 8 -14 of parenteral acyclovir, 3 pk levels to be drawn (drawn 30 minutes prior to infusion, 15 minutes after completion of infusion, and 3-4 hours after infusion)
Awards & highlights

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.

Who is the study for?
This trial is for newborns aged 2-12 weeks, weighing at least 2000 grams, born after ≥34 weeks of gestation, with confirmed neonatal herpes simplex virus. They must have started parenteral acyclovir within the first 42 days of life and not be on other investigational drugs or have conditions affecting drug metabolism.Check my eligibility
What is being tested?
The study tests Valacyclovir's effects in infants with neonatal herpes compared to standard intravenous acyclovir treatment. It aims to understand how Valacyclovir works in the body (pharmacokinetics) and its safety over a period of up to five years.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical antiviral reactions such as headache, nausea, vomiting, diarrhea, or more serious risks like kidney problems due to medication processing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I started acyclovir treatment when I was 42 days old or younger.
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I am on a short-term acyclovir treatment prescribed by my doctor.
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My HSV infection has been confirmed by a lab test.
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I was born after 34 weeks of pregnancy.
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My weight is at least 2000 grams at the time of joining the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one pk level drawn randomly on days 1-7; in addition, on one day between day 8 -14 of parenteral acyclovir, 3 pk levels to be drawn (drawn 30 minutes prior to infusion, 15 minutes after completion of infusion, and 3-4 hours after infusion)
This trial's timeline: 3 weeks for screening, Varies for treatment, and one pk level drawn randomly on days 1-7; in addition, on one day between day 8 -14 of parenteral acyclovir, 3 pk levels to be drawn (drawn 30 minutes prior to infusion, 15 minutes after completion of infusion, and 3-4 hours after infusion) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the curve following administration of oral valacyclovir suspension 20 mg/kg every 8 hours
Secondary outcome measures
Area under the curve following administration of parenteral acyclovir 20 mg/kg every 8 hours
Comparison of the Area under the curve of 20 mg/kg IV acyclovir to the area under the curve of 20 mg/kg PO valacyclovir

Side effects data

From 2011 Phase 3 trial • 91 Patients • NCT00031486
40%
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%
Blood creatinine increased
8%
Syncope
8%
Pyrexia
8%
Tremor
8%
Chest pain
5%
Irritability
5%
Parosmia
5%
White blood cells urine positive
5%
Reticulocyte count abnormal
5%
Back pain
5%
Dizziness
5%
Encephalitis herpes
5%
Muscular weakness
5%
Paraesthesia
5%
Dysgeusia
5%
Hallucinaion
5%
Convulsion
5%
Ageusia
5%
Alanine aminotransferase increased
5%
Arthralgia
5%
Candidiasis
5%
Hyperreflexia
3%
Creatinine renal clearance decreased
3%
Blood uric acid abnormal
3%
Depressed level of consciousness
3%
Stress
3%
Confusional state
3%
Blood urea
3%
Weight increased
3%
Retinal ischaemia
3%
Nightmares
3%
Oedema peripheral
3%
Blood uric acid decreased
3%
Meralgia paraesthetica
3%
Osteoarthritis
3%
Abdominal pain
3%
Dysaesthesia
3%
Amnesia
3%
Pharyngitis
3%
Vulvovaginal mycotic infection
3%
Suicide attempt
3%
Aphthous stomatitis
3%
Diarrhoea
3%
Dysphagia
3%
Asthenia
3%
Embolism
3%
Encephalitis
3%
Fall
3%
Papillary thyroid cancer
3%
Pulmonary embolism
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%
Haemoglobin decreased
3%
Haemorrhage intracranial
3%
Musculoskeletal discomfort
3%
Musculoskeletal disorder
3%
Neck pain
3%
Nervousness
3%
Neutrophil count abnormal
3%
Panic attack
3%
Pharyngitis streptococcal
3%
Sialoadenitis
3%
Tooth loss
3%
Upper respiratory tract infection
3%
Urine analysis abnormal
3%
Urosepsis
3%
Dry mouth
3%
Billiary dyskinesia
3%
Brain abscess
3%
Cerebral infarction
3%
Cerebrovascular accident
3%
Coagulopathy
3%
Renal failure acute
3%
Agitation
3%
Alanine aminotransferase abnormal
3%
Anosmia
3%
Diverticulitis
3%
Gingival hyperplasia
3%
Herpes zoster
3%
Loss of consciousness
3%
Migraine
3%
Nystagmus
3%
Radial nerve palsy
3%
Red blood cell count abnormal
3%
Salivary hypersecretion
3%
Lymphadenectomy
3%
Blood glucose increased
3%
Agitated depression
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

1Treatment groups
Experimental Treatment
Group I: Neonatal HSV disease requiring suppressive therapyExperimental Treatment1 Intervention
All subjects enrolled in the study will receive 2 (up to 7) days of valacyclovir 20 mg/kg every 8 hours after completion of standard of care treatment course with acyclovir.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valaciclovir
FDA approved

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,571 Previous Clinical Trials
2,269,401 Total Patients Enrolled
Richard Whitley, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
4 Previous Clinical Trials
13,468 Total Patients Enrolled

Media Library

Valacyclovir (Anti-viral) Clinical Trial Eligibility Overview. Trial Name: NCT04448392 — Phase 1
Neonatal Herpes Research Study Groups: Neonatal HSV disease requiring suppressive therapy
Neonatal Herpes Clinical Trial 2023: Valacyclovir Highlights & Side Effects. Trial Name: NCT04448392 — Phase 1
Valacyclovir (Anti-viral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04448392 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Are elderly people above 85 eligible for this investigation?

"According to the listed qualifications, participants must lie within 2-12 Weeks of age."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~4 spots leftby Oct 2025