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Trial record 13 of 112 for:    acyclovir

Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

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ClinicalTrials.gov Identifier: NCT00855309
Recruitment Status : Completed
First Posted : March 4, 2009
Results First Posted : November 25, 2013
Last Update Posted : July 6, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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
Enrollment 112
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Weight-based IV Acyclovir Low-dose IV Acyclovir
Hide Arm/Group Description Patients receive weight-based IV acyclovir sodium every 8 or 12 hours. Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
Period Title: Overall Study
Started 57 55
Completed 56 55
Not Completed 1 0
Reason Not Completed
patient never recieved drug             1             0
Arm/Group Title Arm I Arm II Total
Hide Arm/Group Description Patients receive weight-based IV acyclovir sodium every 8 or 12 hours. Patients receive low-dose IV acyclovir sodium every 8 or 12 hours. Total of all reporting groups
Overall Number of Baseline Participants 57 55 112
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 55 participants 112 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants 55 participants 112 participants
55.3  (13.5) 53.3  (14.4) 54.4  (14.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 55 participants 112 participants
Female
24
  42.1%
27
  49.1%
51
  45.5%
Male
33
  57.9%
28
  50.9%
61
  54.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 57 participants 55 participants 112 participants
57 55 112
1.Primary Outcome
Title Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline
Hide Description [Not Specified]
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II
Hide Arm/Group Description:
Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
Overall Number of Participants Analyzed 56 55
Measure Type: Number
Unit of Measure: participants
2 3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I Arm II
Hide Arm/Group Description Patients receive weight-based IV acyclovir sodium every 8 or 12 hours. Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
All-Cause Mortality
Arm I Arm II
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I Arm II
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/56 (0.00%)      0/55 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I Arm II
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/56 (3.57%)      3/55 (5.45%)    
Renal and urinary disorders     
Nephrotoxicity   2/56 (3.57%)  2 3/55 (5.45%)  3
Indicates events were collected by systematic assessment
per the protocol, only nephrotoxicities (as measured by Creatinine increase over baseline were observed.
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
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00855309     History of Changes
Other Study ID Numbers: IRB00007690
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: July 6, 2018