Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia
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.
|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|
- Incidence of nephrotoxicity, defined as a serum creatinine ≥ 2 times the patient's baseline [ Designated as safety issue: Yes ]
- 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 ]
|Study Start Date:||November 2008|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
Drug: acyclovir sodium
Experimental: Arm II
Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
Drug: acyclovir sodium
- 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.
|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|
|Principal Investigator:||M. Jay Brown, PharmD||Comprehensive Cancer Center of Wake Forest University|