Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|