Herpes SimplexPhase 1NCT00297206
A Safety And Tolerability Study Of Valaciclovir Oral Suspension In Infants And Children
A Phase 1 study testing Valaciclovir in people with Herpes Simplex, run by GlaxoSmithKline at 13 sites in 3 countries.
Trial summary
Limited data are available on valaciclovir use in children and valaciclovir is not currently approved for use in pediatrics. The marketed formulation of valaciclovir is not ideal for use in pre-adolescent patients who may have trouble swallowing solid oral dosage forms. Read more about this study
- Who is it for?
- Ages 1 month to 6 years
- Conditions the study is for
- Herpes Simplex
- What is being tested?
- Valaciclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 25 Jan 2003to 28 Feb 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects who have a current herpes virus infection.
- Have neonatally acquired herpes at risk of potential recurrence.
- Immunocompromised or cancer patients at risk for development of a herpes virus infection.
Who cannot join
- Hypersensitivity to antiherpetic medications.
- Impaired hepatic or renal function.
- Show presence of other serious or unstable underlying disease.
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
United States10 sites
GSK Investigational Site
Birmingham, Alabama, 35233
GSK Investigational Site
Cincinnati, Ohio, 45229
GSK Investigational Site
Durham, North Carolina, 27705
GSK Investigational Site
Galveston, Texas, 77555-0653
GSK Investigational Site
Jacksonville, Florida, 32209
GSK Investigational Site
Lexington, Kentucky, 40503
GSK Investigational Site
Little Rock, Arkansas, 72202
GSK Investigational Site
Louisville, Kentucky, 40202
GSK Investigational Site
New Orleans, Louisiana, 70112
GSK Investigational Site
San Diego, California, 92123
South Africa2 sites
GSK Investigational Site
Brits, 2000
GSK Investigational Site
George, 6529
Chile1 site
GSK Investigational Site
Santiago, Región Metro de Santiago, 7580206
About this study
Official title: An Open-label, Single-dose, Multicenter, Pharmacokinetic, Safety and Tolerability Study of Valaciclovir Oral Suspension in Infants and Children.
Limited data are available on valaciclovir use in children and valaciclovir is not currently approved for use in pediatrics. The marketed formulation of valaciclovir is not ideal for use in pre-adolescent patients who may have trouble swallowing solid oral dosage forms. An extemporaneous suspension formulation of valaciclovir has been developed to expedite the provision of benefits to children similar to those from administration of valaciclovir solid formulations in adults.
- Conditions
- Herpes Simplex
- Being tested
- Valaciclovir
- Keywords
- pharmacokinetics herpes varicella herpes labialis Epstein-Barr virus
- Medical subject headings
- Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValaciclovirDrug
Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Subjects in the age group of 2 to less than 6 years will be included Receives: Drug: Valaciclovir |
| Cohort 2 | Experimental | Subjects in the age group of 1 to less than 2 years will be included Receives: Drug: Valaciclovir |
| Cohort 3 | Experimental | Subjects in the age group of 6 months to less than 1 year will be included Receives: Drug: Valaciclovir |
| Cohort 4 | Experimental | Subjects in the age group of 3 months to less than 6 months will be included Receives: Drug: Valaciclovir |
| Cohort 5 | Experimental | Subjects in the age group of 1 month to less than 3 months will be included Receives: Drug: Valaciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma acyclovir and valaciclovir concentrations pre-dose (within 15 minutes of dose administration) and at 0.5, 1, 2, 4 and 6 hours following administration of the valaciclovir oral suspension dose.
Measured: 0.5, 1, 2, 4 and 6 hours
Secondary outcomes (1)
Safety monitoring throughout the study and at the follow up evaluation 2-4 days after the single dose of study medication.
Measured: Up to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2006 (estimated)
- Study start25 Jan 2003
- Primary completion28 Feb 2007
- Study completion28 Feb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Herpes SimplexStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297206
- Sponsor's protocol ID
- HS210914
- Status last verified
- Sep 2017
- First submitted
- 24 Feb 2006
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Bradley J, Scholtz F, Brennan C, Zhao H, Weller S. Pharmacokinetics and safety of single-dose valacyclovir oral suspension in infants and children with current or potential herpesvirus infection. Poster presentation, 45th Annual Meeting Infectious Disease
Kimberlin DW, Jacobs RF, Weller S, van der Walt JS, Heitman CK, Man CY, Bradley JS. Pharmacokinetics and safety of extemporaneously compounded valacyclovir oral suspension in pediatric patients from 1 month through 11 years of age. Clin Infect Dis. 2010 Jan 15;50(2):221-8. doi: 10.1086/649212.
PubMed 20014952
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose, Multicenter, Pharmacokinetic, Safety and Tolerability Study of Valaciclovir Oral Suspension in Infants and Children.
- ClinicalTrials.gov ID
- NCT00297206
- Acronym / sponsor ID
- HS210914
- Conditions
- Herpes Simplex
- Keywords
- pharmacokinetics herpes varicella herpes labialis Epstein-Barr virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2003 (actual)
- Primary completion
- 28 Feb 2007 (actual)
- Study completion
- 28 Feb 2007 (actual)
- First posted
- 28 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Limited data are available on valaciclovir use in children and valaciclovir is not currently approved for use in pediatrics. The marketed formulation of valaciclovir is not ideal for use in pre-adolescent patients who may have trouble swallowing solid oral dosage forms. An extemporaneous suspension formulation of valaciclovir has been developed to expedite the provision of benefits to children similar to those from administration of valaciclovir solid formulations in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: ValaciclovirSubjects in the age group of 2 to less than 6 years will be included |
| Cohort 2 | Experimental | Drug: ValaciclovirSubjects in the age group of 1 to less than 2 years will be included |
| Cohort 3 | Experimental | Drug: ValaciclovirSubjects in the age group of 6 months to less than 1 year will be included |
| Cohort 4 | Experimental | Drug: ValaciclovirSubjects in the age group of 3 months to less than 6 months will be included |
| Cohort 5 | Experimental | Drug: ValaciclovirSubjects in the age group of 1 month to less than 3 months will be included |
Who may qualify
- Ages
- 1 month to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subjects who have a current herpes virus infection.
- Have neonatally acquired herpes at risk of potential recurrence.
- Immunocompromised or cancer patients at risk for development of a herpes virus infection.
Key exclusion criteria (3 listed)
- Hypersensitivity to antiherpetic medications.
- Impaired hepatic or renal function.
- Show presence of other serious or unstable underlying disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ValaciclovirValaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
Plasma acyclovir and valaciclovir concentrations pre-dose (within 15 minutes of dose administration) and at 0.5, 1, 2, 4 and 6 hours following administration of the valaciclovir oral suspension dose.
Time frame: 0.5, 1, 2, 4 and 6 hours
1 secondary outcome
Safety monitoring throughout the study and at the follow up evaluation 2-4 days after the single dose of study medication.
Time frame: Up to Day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- BackgroundBradley J, Scholtz F, Brennan C, Zhao H, Weller S. Pharmacokinetics and safety of single-dose valacyclovir oral suspension in infants and children with current or potential herpesvirus infection. Poster presentation, 45th Annual Meeting Infectious Disease
- Background: PubMed 20014952Kimberlin DW, Jacobs RF, Weller S, van der Walt JS, Heitman CK, Man CY, Bradley JS. Pharmacokinetics and safety of extemporaneously compounded valacyclovir oral suspension in pediatric patients from 1 month through 11 years of age. Clin Infect Dis. 2010 Jan 15;50(2):221-8. doi: 10.1086/649212.
- Results for study HS210914 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Valaciclovir in people with Herpes Simplex, run by GlaxoSmithKline at 13 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, South Africa, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma acyclovir and valaciclovir concentrations pre-dose (within 15 minutes of dose administration) and at 0.5, 1, 2, 4 and 6 hours following administration of the valaciclovir oral suspension dose. (time frame: 0.5, 1, 2, 4 and 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00297206, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.