Trial record 1 of 30 for:
Open Studies | "Herpes Simplex"
Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia
This study is currently recruiting participants.
Verified January 2013 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Comprehensive Cancer Center of Wake Forest University
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00855309
First received: March 3, 2009
Last updated: January 25, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Herpes Simplex |
Drug: acyclovir sodium |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Low Dose Versus Weight-based Intravenous Acyclovir for Herpes Simplex Virus Prophylaxis in the Neutropenic Patient |
Resource links provided by NLM:
Further study details as provided by Comprehensive Cancer Center of Wake Forest University:
Primary Outcome Measures:
- Incidence of nephrotoxicity, defined as a serum creatinine ≥ 2 times the patient's baseline [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Incidence of clinical herpes simplex viral infection, defined as culture (+) from a lesion and a clinical picture of infection [ Designated as safety issue: No ]
- Incidence of adverse events other than nephrotoxicity [ Designated as safety issue: Yes ]
- Time to nephrotoxicity [ Designated as safety issue: No ]
- Median peak serum creatinine [ Designated as safety issue: No ]
- Incidence of a 25% decrease in creatinine clearance [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2008 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
|
Drug: acyclovir sodium
Given IV
|
|
Experimental: Arm II
Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
|
Drug: acyclovir sodium
Given IV
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- Active HSV infection, as evidenced by any of the following:
- Positive HSV cultures
- Oral lesions
- Receiving 5 mg/kg acyclovir sodium every 8 hours
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855309
Locations
| United States, North Carolina | |
| Wake Forest University Comprehensive Cancer Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771 | |
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
| Principal Investigator: | M. Jay Brown, PharmD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Comprehensive Cancer Center of Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT00855309 History of Changes |
| Other Study ID Numbers: | CDR0000633817, P30CA012197, CCCWFU-98608, IRB00007690 |
| Study First Received: | March 3, 2009 |
| Last Updated: | January 25, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Comprehensive Cancer Center of Wake Forest University:
|
chemotherapeutic agent toxicity renal toxicity infection neutropenia |
Additional relevant MeSH terms:
|
Herpes Simplex Neutropenia Herpesviridae Infections DNA Virus Infections Virus Diseases Skin Diseases, Viral Skin Diseases, Infectious Skin Diseases Agranulocytosis |
Leukopenia Leukocyte Disorders Hematologic Diseases Acyclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013