Herpes SimplexPhase 3NCT00855309
Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia
A Phase 3 study testing acyclovir sodium in people with Herpes Simplex, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
RATIONALE: Acyclovir may be effective in preventing herpes simplex virus infection in patients with neutropenia. PURPOSE: This randomized phase III trial is studying the side effects of acyclovir and is comparing two doses of acyclovir in preventing herpes simplex virus infection in patients with neutropenia. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Herpes Simplex
- What is being tested?
- acyclovir sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Nov 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18 years of age or older.
- Receiving treatment in inpatient oncology services at Wake Forest University Baptist Medical Center
- Receiving chemotherapy or have received chemotherapy within the past 2 weeks
- Seropositive herpes simplex virus (HSV)-1 or HSV-2 immunoglobulin antibody assay
- Creatinine clearance ≥ 50 mL/min
- Intravenous acyclovir sodium therapy is deemed necessary by the physician based upon clinical judgement (i.e., mucositis, vomiting, decreased GI absorption)
Who cannot join
- Pregnant or nursing
- Hypersensitivity to acyclovir sodium
- High tumor burden (i.e., WBC > 50,000/mm^3 at admission)
- Neutropenic, defined as one of the following:
- ANC < 500/mm^3
- ANC < 1,000/mm^3 with a predicted decrease to 500/mm^3
Show all 10Show fewer
- Active HSV infection, as evidenced by any of the following:
- Positive HSV cultures
- Oral lesions
- Receiving 5 mg/kg acyclovir sodium every 8 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: Low Dose Versus Weight-based Intravenous Acyclovir for Herpes Simplex Virus Prophylaxis in the Neutropenic Patient
RATIONALE: Acyclovir may be effective in preventing herpes simplex virus infection in patients with neutropenia.
PURPOSE: This randomized phase III trial is studying the side effects of acyclovir and is comparing two doses of acyclovir in preventing herpes simplex virus infection in patients with neutropenia.
Read the detailed description
OBJECTIVES:
- To determine the difference in nephrotoxicity between low-dose and weight-based intravenous acyclovir sodium as herpes simplex virus infection prophylaxis in patients with neutropenia.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
- Arm II: Patients receive low-dose IV acyclovir sodium every 8 or 12 hours. Treatment continues for approximately 2 weeks unless clinical herpes simplex virus infection is confirmed or the patient is no longer neutropenic.
- Conditions
- Herpes Simplex
- Being tested
- acyclovir sodium
- Keywords
- chemotherapeutic agent toxicity, renal toxicity, infection, neutropenia
- Medical subject headings
- Herpes Simplex, Infections, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acyclovir sodiumDrug
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive weight-based IV acyclovir sodium every 8 or 12 hours. Receives: Drug: acyclovir sodium |
| Arm II | Experimental | Patients receive low-dose IV acyclovir sodium every 8 or 12 hours. Receives: Drug: acyclovir sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startNov 2008
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Herpes SimplexStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- M. Jay Brown, PharmD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855309
- Sponsor's protocol ID
- IRB00007690
- Other IDs
- P30CA012197, CCCWFU-98608, IRB00007690
- Status last verified
- Jul 2018
- First submitted
- 3 Mar 2009
- Last updated
- 6 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Versus Weight-based Intravenous Acyclovir for Herpes Simplex Virus Prophylaxis in the Neutropenic Patient
- ClinicalTrials.gov ID
- NCT00855309
- Acronym / sponsor ID
- IRB00007690
- Conditions
- Herpes Simplex
- Keywords
- chemotherapeutic agent toxicity, renal toxicity, infection, neutropenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2008
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 4 Mar 2009 (estimated)
- Results
- Posted 25 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Acyclovir may be effective in preventing herpes simplex virus infection in patients with neutropenia.
PURPOSE: This randomized phase III trial is studying the side effects of acyclovir and is comparing two doses of acyclovir in preventing herpes simplex virus infection in patients with neutropenia.
Detailed description
OBJECTIVES:
- To determine the difference in nephrotoxicity between low-dose and weight-based intravenous acyclovir sodium as herpes simplex virus infection prophylaxis in patients with neutropenia.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
- Arm II: Patients receive low-dose IV acyclovir sodium every 8 or 12 hours. Treatment continues for approximately 2 weeks unless clinical herpes simplex virus infection is confirmed or the patient is no longer neutropenic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: acyclovir sodiumPatients receive weight-based IV acyclovir sodium every 8 or 12 hours. |
| Arm II | Experimental | Drug: acyclovir sodiumPatients receive low-dose IV acyclovir sodium every 8 or 12 hours. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be 18 years of age or older.
- Receiving treatment in inpatient oncology services at Wake Forest University Baptist Medical Center
- Receiving chemotherapy or have received chemotherapy within the past 2 weeks
- Seropositive herpes simplex virus (HSV)-1 or HSV-2 immunoglobulin antibody assay
- Creatinine clearance ≥ 50 mL/min
Key exclusion criteria (10 listed)
- Pregnant or nursing
- Hypersensitivity to acyclovir sodium
- High tumor burden (i.e., WBC > 50,000/mm^3 at admission)
- Neutropenic, defined as one of the following:
- ANC < 500/mm^3
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 |
|---|---|---|
| acyclovir sodiumGiven IV | Drug | Arm I, Arm II |
Primary outcome
Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Herpes Simplex
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
Not yet recruitingPhase 2
Study to Compare GS-1179 Versus Valacyclovir in HSV-2 Seropositive Participants With Recurrent Genital Herpes
HSV-2 Infection
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.
M. Jay Brown, PharmD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing acyclovir sodium in people with Herpes Simplex, run by Wake Forest University Health Sciences at 1 site 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 6 inclusion and 10 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 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline (time frame: 24 hours). It is what the study was designed to measure, not a finding.
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 6 Jul 2018.