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Trial record 43 of 112 for:    acyclovir

Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2

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ClinicalTrials.gov Identifier: NCT00362297
Recruitment Status : Completed
First Posted : August 9, 2006
Results First Posted : October 8, 2014
Last Update Posted : October 8, 2014
Sponsor:
Information provided by (Responsible Party):
Christine Johnston, University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Genital Herpes
Interventions Drug: acyclovir
Drug: valacyclovir
Enrollment 31
Recruitment Details Dates of recruitment: November 2006-August 2008 Site: University of Washington Virology Research Clinic, Seattle, WA
Pre-assignment Details  
Arm/Group Title Standard Dose High-dose
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Arm 1 (Initial Drug Assignment)
Started 16 15
Completed 16 11
Not Completed 0 4
Reason Not Completed
Lost to Follow-up             0             4
Period Title: Arm 2 (Cross-over to Other Dose)
Started 16 11
Completed 16 11
Not Completed 0 0
Arm/Group Title Standard Dose High-dose Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 16 15 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 15 participants 31 participants
41.6  (13.2) 39.1  (12.2) 40.5  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
Female
10
  62.5%
9
  60.0%
19
  61.3%
Male
6
  37.5%
6
  40.0%
12
  38.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   6.7%
1
   3.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   6.3%
2
  13.3%
3
   9.7%
White
13
  81.3%
10
  66.7%
23
  74.2%
More than one race
2
  12.5%
0
   0.0%
2
   6.5%
Unknown or Not Reported
0
   0.0%
2
  13.3%
2
   6.5%
1.Primary Outcome
Title Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir.
Hide Description Participants were treated with both interventions in a cross-over study design. Shedding rates on each drug arm per participant were compared by Poisson regression.
Time Frame 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who did not collect at least one swab on each arm of the cross-over were excluded from analysis.
Arm/Group Title Standardy Dose Valacyclovir High Dose Acyclovir
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 27 27
Measure Type: Number
Unit of Measure: percentage of swabs with HSV detected
4 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standardy Dose Valacyclovir
Comments Comparison of genital HSV shedding rate on high dose acyclovir to standard dose valacyclovir. Powered with 80% chance of detecting 50% reduction in genital shedding rate on high dose acyclovir compared to standard dose valacyclovir.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method Regression, Poisson
Comments Adjusted for period effects.
Method of Estimation Estimation Parameter Incident Risk Ratio
Estimated Value 0.79
Confidence Interval 95%
0.63 to 1.00
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Frequency of Subclinical Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir.
Hide Description [Not Specified]
Time Frame 15 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Frequency of Lesional Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per Day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir.
Hide Description [Not Specified]
Time Frame 15 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Number of Herpes Recurrences, Defined Clinically as >=1 Successive Day on Which Genital Lesions Are Present, in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir.
Hide Description [Not Specified]
Time Frame 15 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Dose High-dose
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Standard Dose High-dose
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Dose High-dose
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/31 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Standard Dose High-dose
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/31 (0.00%) 
The trial was performed at a single site, and enrolled mostly white, healthy, sexually active adults with high rates of genital HSV-2 recurrence. The results may not be generalizable to other populations.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Christine Johnston
Organization: University of Washington
Phone: 206-520-4340
Responsible Party: Christine Johnston, University of Washington
ClinicalTrials.gov Identifier: NCT00362297     History of Changes
Other Study ID Numbers: 30520-D - Phase 1
First Submitted: August 8, 2006
First Posted: August 9, 2006
Results First Submitted: March 23, 2012
Results First Posted: October 8, 2014
Last Update Posted: October 8, 2014