ShinglesPhase 1NCT00059592
Valacyclovir in Immunocompromised Children
A Phase 1 study testing Valacyclovir in people with Shingles and Bone Marrow Transplantation, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
Shingles is an infection commonly seen in children with a weakened immune system (immunocompromised children). The immune system can be weakened as a result of medications that patients receive for cancer or other serious illness or as a result of a bone marrow transplantation. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Shingles, Bone Marrow Transplantation
- What is being tested?
- Valacyclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Apr 1998to 5 May 2005
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients must be >/= 2 and </= 18 years old.
- Patients must have a life expectancy of > 8 weeks.
- Patients must be receiving chemotherapy or have been treated with bone marrow transplantation or chemotherapy for an underlying malignancy or medical condition in the past 12 months, or have an underlying immunodeficiency syndrome.
- Patients must have adequate hepatic function (bilirubin ≤ 1.5 mg/dl: SGPT < 3x normal) and adequate renal function (creatinine ≤ 1.2 mg/dl or creatinine clearance ≥ 60 ml/min/1.73 m2).
- Acute Zoster Infection: Patients must have acute herpes zoster defined as </= 3 days of rash, limited to 3 or less dermatomes, and no evidence of dissemination (organ involvement e.g. hepatitis, pneumonitis, encephalitis).
- Patients must be able to swallow pills or tolerate a suspension of the medication.
Show all 9Show fewer
- Children must be able to retain liquids at the time of enrollment.
- Written informed consent will be obtained from all patients and/or their parents prior to enrollment.
- Bone Marrow Transplant Patients: Patients without acute zoster infection, but with positive HSV serology who will be treated with acyclovir prophylaxis during the pretransplant period are eligible.
Who cannot join
- Patients with evidence of disseminated VZV infection, as documented by dermatomal zoster at more than 3 dermatomes.
- Patients with history of VZV infection > 3 days.
- Patients in relapse, (Stratum I only), or unstable medical conditions due to underlying disease.
- Patients with suspected acyclovir-resistant VZV infection.
- Patients who received systemic antiherpetic therapy in the previous 2 weeks before the onset of VZV infection.
- Patients with known history of adverse reaction to acyclovir in the past.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas Children's Hospital
Houston, Texas, 77030
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Shingles is an infection commonly seen in children with a weakened immune system (immunocompromised children). The immune system can be weakened as a result of medications that patients receive for cancer or other serious illness or as a result of a bone marrow transplantation. Shingles in children with a weakened immune system may spread throughout the body and in some instances may be life-threatening. Acyclovir is a medication that is routinely used to treat immunocompromised children with shingles in order to prevent further spread of their shingles and to help them heal faster. Acyclovir is also given to bone marrow transplant patients to prevent reactivation of HSV infection.
Valacyclovir is a new drug that is metabolized (broken down in the body) to acyclovir. Valacyclovir is given by mouth and studies done in adults have shown it to be more effective than acyclovir given by mouth.
Read more
The purpose of this study is to
- study the pharmacology of this drug (how the body handles this drug),
- determine if oral Valacyclovir can be safely given to children with shingles, and
- determine the type of side effects that occur when oral Valacyclovir is given to immunocompromised children.
Read the detailed description
Patients with shingles:
Patients with shingles will receive oral Valacyclovir three times a day for 5 to 10 days. For the first 24 hours of treatment, patients will be admitted to the hospital for close monitoring. If there are no problems after the first 24 hours then the patient may be discharged to take the medicine at home.
After discharge patients will be seen and examined in clinic daily for the first 5 days, then on day 7 and after that every other day until the shingles show evidence of healing. A final physical exam and blood tests occur on day 21.
A small amount of fluid will be taken from one of the shingles lesions using a very fine needle to verify the presence of the virus that causes shingles. This will be done before the first dose of Valacyclovir and 3 days later.
Blood tests (no more than 2 teaspoons) will be performed twice a week to monitor for toxic effects of the drug. Blood samples will be drawn to evaluate the pharmacology of this drug(how the body handles the drug). Nine blood samples (less than one teaspoon each) will be obtained over 24 hours during the first day of treatment. The total amount of blood to be drawn is 9 teaspoons (3 tablespoons).
For children that are toilet trained, urine will be collected for 12 hours at the start of the study. This urine will be used to evaluate kidney function, and the pharmacology of valacyclovir. If there are unacceptable side effects or if there is evidence that the disease is spreading, despite being on Valacyclovir for more than 48 hours, then you will be taken off the study and started on acyclovir by vein.
Patients Undergoing Bone Marrow Transplantation:
Patients undergoing a bone marrow transplant will receive a single dose of valacyclovir in place of their first scheduled dose of acyclovir. They will then receive acyclovir as outlined by their physician.
Blood samples will be drawn to evaluate the pharmacology (how the body handles the drug) of the study drug. Fifteen blood samples (less than one teaspoon each) will be obtained over 24 hours during the first day of treatment. The total amount of blood to be drawn is 9 teaspoons (3 tablespoons. The total amount of blood drawn for all blood work including routine blood tests as well as pharmacokinetics will not be greater than 5% of the patients total blood volume. This amount of blood loss is a safe amount even for small children
- Conditions
- Shingles, Bone Marrow Transplantation
- Being tested
- Valacyclovir
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValacyclovirDrug
Also called Valtrex
| Study group | Role | What they receive |
|---|---|---|
| Valacyclovir | Experimental | oral Valacyclovir three times a day for 5 to 10 days. Receives: Drug: Valacyclovir |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2003 (estimated)
- Study start7 Apr 1998
- Primary completion30 Dec 2004
- Study completion5 May 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShinglesStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Blaney, Baylor College of Medicine
- Investigators
- Susan Blaney, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00059592
- Sponsor's protocol ID
- H6644
- Status last verified
- Mar 2020
- First submitted
- 29 Apr 2003
- Last updated
- 4 Mar 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valacyclovir in Immunocompromised Children
- ClinicalTrials.gov ID
- NCT00059592
- Acronym / sponsor ID
- H6644
- Conditions
- Shingles, Bone Marrow Transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 7 Apr 1998 (actual)
- Primary completion
- 30 Dec 2004 (actual)
- Study completion
- 5 May 2005 (actual)
- First posted
- 30 Apr 2003 (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.
Shingles is an infection commonly seen in children with a weakened immune system (immunocompromised children). The immune system can be weakened as a result of medications that patients receive for cancer or other serious illness or as a result of a bone marrow transplantation. Shingles in children with a weakened immune system may spread throughout the body and in some instances may be life-threatening. Acyclovir is a medication that is routinely used to treat immunocompromised children with shingles in order to prevent further spread of their shingles and to help them heal faster. Acyclovir is also given to bone marrow transplant patients to prevent reactivation of HSV infection.
Valacyclovir is a new drug that is metabolized (broken down in the body) to acyclovir. Valacyclovir is given by mouth and studies done in adults have shown it to be more effective than acyclovir given by mouth.
The purpose of this study is to
- study the pharmacology of this drug (how the body handles this drug),
- determine if oral Valacyclovir can be safely given to children with shingles, and
- determine the type of side effects that occur when oral Valacyclovir is given to immunocompromised children.
Detailed description
Patients with shingles:
Patients with shingles will receive oral Valacyclovir three times a day for 5 to 10 days. For the first 24 hours of treatment, patients will be admitted to the hospital for close monitoring. If there are no problems after the first 24 hours then the patient may be discharged to take the medicine at home.
After discharge patients will be seen and examined in clinic daily for the first 5 days, then on day 7 and after that every other day until the shingles show evidence of healing. A final physical exam and blood tests occur on day 21.
A small amount of fluid will be taken from one of the shingles lesions using a very fine needle to verify the presence of the virus that causes shingles. This will be done before the first dose of Valacyclovir and 3 days later.
Blood tests (no more than 2 teaspoons) will be performed twice a week to monitor for toxic effects of the drug. Blood samples will be drawn to evaluate the pharmacology of this drug(how the body handles the drug). Nine blood samples (less than one teaspoon each) will be obtained over 24 hours during the first day of treatment. The total amount of blood to be drawn is 9 teaspoons (3 tablespoons).
For children that are toilet trained, urine will be collected for 12 hours at the start of the study. This urine will be used to evaluate kidney function, and the pharmacology of valacyclovir. If there are unacceptable side effects or if there is evidence that the disease is spreading, despite being on Valacyclovir for more than 48 hours, then you will be taken off the study and started on acyclovir by vein.
Patients Undergoing Bone Marrow Transplantation:
Patients undergoing a bone marrow transplant will receive a single dose of valacyclovir in place of their first scheduled dose of acyclovir. They will then receive acyclovir as outlined by their physician.
Blood samples will be drawn to evaluate the pharmacology (how the body handles the drug) of the study drug. Fifteen blood samples (less than one teaspoon each) will be obtained over 24 hours during the first day of treatment. The total amount of blood to be drawn is 9 teaspoons (3 tablespoons. The total amount of blood drawn for all blood work including routine blood tests as well as pharmacokinetics will not be greater than 5% of the patients total blood volume. This amount of blood loss is a safe amount even for small children
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valacyclovir | Experimental | Drug: Valacycloviroral Valacyclovir three times a day for 5 to 10 days. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Patients must be >/= 2 and </= 18 years old.
- Patients must have a life expectancy of > 8 weeks.
- Patients must be receiving chemotherapy or have been treated with bone marrow transplantation or chemotherapy for an underlying malignancy or medical condition in the past 12 months, or have an underlying immunodeficiency syndrome.
- Patients must have adequate hepatic function (bilirubin ≤ 1.5 mg/dl: SGPT < 3x normal) and adequate renal function (creatinine ≤ 1.2 mg/dl or creatinine clearance ≥ 60 ml/min/1.73 m2).
- Acute Zoster Infection: Patients must have acute herpes zoster defined as </= 3 days of rash, limited to 3 or less dermatomes, and no evidence of dissemination (organ involvement e.g. hepatitis, pneumonitis, encephalitis).
Key exclusion criteria (6 listed)
- Patients with evidence of disseminated VZV infection, as documented by dermatomal zoster at more than 3 dermatomes.
- Patients with history of VZV infection > 3 days.
- Patients in relapse, (Stratum I only), or unstable medical conditions due to underlying disease.
- Patients with suspected acyclovir-resistant VZV infection.
- Patients who received systemic antiherpetic therapy in the previous 2 weeks before the onset of VZV infection.
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 |
|---|---|---|
| ValacyclovirAlso: Valtrex | Drug | Valacyclovir |
Primary outcome
Not reported in the source record.
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 4 Mar 2020.
Related trials for Shingles
Not yet recruitingPhase 1/2
Immunogenicity and Safety of SYS6052 in the Participants Aged 40 Years and Above
Herpes Zoster
Not yet recruitingPhase 2
A Study Exploring the Effect of Adjuvanted RZV or RSVPreF3 Vaccines on Coronary Plaque Progression in Adults >=50 Years of Age at Risk for Cardiovascular Events
Cardiovascular Disease
Active, not recruitingPhase 3
Efficacy, Safety and Immunogenicity Study of Recombinant Zoster Vaccine(CHO Cell) in Adults Aged 40 Years and Older
Herpes Zoster
Active, not recruitingPhase 1/2
Safety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults 50 Years of Age and Over
Shingles, Herpes Zoster
Active, not recruitingPhase 3
A Phase III Clinical Trial to Evaluate Long-Term Protective Efficacy of Recombinant Zoster Vaccine (CHO Cell)
Herpes Zoster
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.
Susan Blaney, MD principal investigator
Baylor College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Valacyclovir in people with Shingles and Bone Marrow Transplantation, run by Baylor College of Medicine at 2 sites in United States.
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 9 inclusion and 6 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 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
Where can I read the original study information?
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 4 Mar 2020.