Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia
This trial is active, not recruiting.
|Sponsor||Comprehensive Cancer Center of Wake Forest University|
|Collaborator||National Cancer Institute (NCI)|
|Start date||November 2008|
|End date||September 2013|
|Trial size||112 participants|
|Trial identifier||NCT00855309, CCCWFU-98608, CDR0000633817, IRB00007690, P30CA012197|
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.
|Intervention model||parallel assignment|
|Primary purpose||supportive care|
Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline
time frame: 24 hours
Male or female participants at least 18 years old.
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
|Official title||Low Dose Versus Weight-based Intravenous Acyclovir for Herpes Simplex Virus Prophylaxis in the Neutropenic Patient|
|Principal investigator||M. Jay Brown, PharmD|
|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.|
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