Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia
|ClinicalTrials.gov Identifier: NCT00855309|
Recruitment Status : Completed
First Posted : March 4, 2009
Results First Posted : November 25, 2013
Last Update Posted : January 19, 2018
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 or disease||Intervention/treatment||Phase|
|Herpes Simplex||Drug: acyclovir sodium||Phase 3|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Low Dose Versus Weight-based Intravenous Acyclovir for Herpes Simplex Virus Prophylaxis in the Neutropenic Patient|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
U.S. FDA Resources
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
- Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline [ Time Frame: 24 hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855309
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Principal Investigator:||M. Jay Brown, PharmD||Wake Forest University Health Sciences|