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Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00855309
First Posted: March 4, 2009
Last Update Posted: August 25, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
Results First Submitted: September 24, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Herpes Simplex
Intervention: Drug: acyclovir sodium

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Weight-based IV Acyclovir Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
Low-dose IV Acyclovir Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.

Participant Flow:   Overall Study
    Weight-based IV Acyclovir   Low-dose IV Acyclovir
STARTED   57   55 
COMPLETED   56   55 
NOT COMPLETED   1   0 
patient never recieved drug                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Arm I   Arm II   Total 
Overall Participants Analyzed 
[Units: Participants]
 57   55   112 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      42  73.7%      39  70.9%      81  72.3% 
>=65 years      15  26.3%      16  29.1%      31  27.7% 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.3  (13.5)   53.3  (14.4)   54.4  (14.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      24  42.1%      27  49.1%      51  45.5% 
Male      33  57.9%      28  50.9%      61  54.5% 
Region of Enrollment 
[Units: Participants]
     
United States   57   55   112 


  Outcome Measures

1.  Primary:   Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline   [ Time Frame: 24 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
per the protocol, only nephrotoxicities (as measured by Creatinine increase over baseline were observed.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: LeAnne Kenndy, PharmD
Organization: Comprehensive Cancer Center of Wake Forest University
phone: 336-713-3416
e-mail: lakenned@wakehealth.edu



Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00855309     History of Changes
Other Study ID Numbers: CDR0000633817
P30CA012197 ( U.S. NIH Grant/Contract )
CCCWFU-98608
IRB00007690
First Submitted: March 3, 2009
First Posted: March 4, 2009
Results First Submitted: September 24, 2013
Results First Posted: November 25, 2013
Last Update Posted: August 25, 2017