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Trial record 12 of 112 for:    acyclovir

A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation

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ClinicalTrials.gov Identifier: NCT00723229
Recruitment Status : Completed
First Posted : July 28, 2008
Results First Posted : March 9, 2017
Last Update Posted : March 9, 2017
Sponsor:
Collaborator:
National Institutes of Health (NIH)
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
Intervention Drug: acyclovir
Enrollment 48
Recruitment Details Participants were recruited between July 2008 and March 2010. Participants were enrolled at the University of Washington Virology Research Clinic, Seattle, WA.
Pre-assignment Details  
Arm/Group Title No Medication First, Then Standard-dose Acyclovir Acyclovir 400 mg Twice Daily First, Followed by no Medication
Hide Arm/Group Description No medication for 4 weeks, then 1 week washout, followed by acyclovir 400 mg twice daily for 4 weeks Acyclovir 400 mg twice daily for 4 weeks, then 1 week washout, followed by no medication for 4 weeks
Period Title: First Intervention
Started 25 23
Completed 18 20
Not Completed 7 3
Reason Not Completed
Lost to Follow-up             7             3
Period Title: Second Intervention
Started 18 20
Completed 18 20
Not Completed 0 0
Arm/Group Title No Medication Acyclovir 400 mg Twice Daily Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 25 23 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 23 participants 48 participants
46.6  (12.3) 42.1  (13.1) 44.4  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 23 participants 48 participants
Female
10
  40.0%
10
  43.5%
20
  41.7%
Male
15
  60.0%
13
  56.5%
28
  58.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 23 participants 48 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  24.0%
5
  21.7%
11
  22.9%
White
17
  68.0%
16
  69.6%
33
  68.8%
More than one race
2
   8.0%
2
   8.7%
4
   8.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
HIV serostatus  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants 23 participants 48 participants
HIV seropositive 9 7 16
HIV seronegative 16 16 32
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 Suppressive Acyclovir as Compared to no Medication in HIV Seronegative and HIV Seropositive Individuals.
Hide Description [Not Specified]
Time Frame 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants collected at least one swab on each study arm
Arm/Group Title No Medication Acyclovir 400 mg Twice Daily
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 38 38
Overall Number of Units Analyzed
Type of Units Analyzed: Swabs
3525 3496
Measure Type: Number
Unit of Measure: percentage of swabs with HSV detected
HIV seronegative Number Analyzed 2123 Swabs [1]  2129 Swabs [1] 
24 3
HIV seropositive Number Analyzed 1402 Swabs [2]  1367 Swabs [2] 
15 7
[1]
23 participants
[2]
15 participants
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Medication, Acyclovir 400 mg Twice Daily
Comments The trial had 80% power to detect a 35% reduction in genital shedding rates for acyclovir 400 mg twice daily.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, poisson
Comments Adjusted for period effects.
Method of Estimation Estimation Parameter Incidence Risk Ratio
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
0.17 to 0.25
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection No Medication, Acyclovir 400 mg Twice Daily
Comments Among HIV seronegative individuals.
Type of Statistical Test Superiority
Comments Adjusted for period effects.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
0.03 to 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection No Medication, Acyclovir 400 mg Twice Daily
Comments Among HIV seropositive individuals.
Type of Statistical Test Superiority
Comments Adjusted for period effects.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
0.4 to 0.6
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Quantity of HSV Detected, Median
Hide Description Median quantity of HSV detected, among swabs with any HSV detected
Time Frame 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of swabs with HSV detected was analyzed. This is a subset of overall numbers of swabs collected, since not all swabs had HSV detected.
Arm/Group Title No Medication Acyclovir 400 mg Twice Daily
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 38 38
Overall Number of Units Analyzed
Type of Units Analyzed: Swabs
587 120
Median (Inter-Quartile Range)
Unit of Measure: log 10 copies/ml
HIV seronegative Number Analyzed 384 Swabs [1]  25 Swabs [1] 
3.3
(2.5 to 5.7)
2.9
(2.4 to 3.4)
HIV seropositive Number Analyzed 203 Swabs [2]  95 Swabs [2] 
5.4
(2.2 to 8.9)
3.3
(2.6 to 6.3)
[1]
23 participants
[2]
15 participants
3.Secondary Outcome
Title Number of Genital HSV Shedding Episodes
Hide Description The number of HSV shedding episodes. A shedding episode is defined as any number of positive swabs preceded and followed by 2 negative swabs
Time Frame 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is the same as the overall number. No participants were excluded from this analysis.
Arm/Group Title No Medication Acyclovir 400 mg Twice Daily
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 38 38
Measure Type: Number
Unit of Measure: Episodes
HIV seronegative Number Analyzed 23 participants 23 participants
49 17
HIV seropositive Number Analyzed 15 participants 15 participants
20 17
4.Secondary Outcome
Title Duration of Genital HSV Shedding Episodes
Hide Description Median duration of HSV shedding episodes, in hours
Time Frame 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only episodes of known duration were included
Arm/Group Title No Medication Acyclovir 400 mg Twice Daily
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 38 38
Overall Number of Units Analyzed
Type of Units Analyzed: Episodes
56 33
Median (Inter-Quartile Range)
Unit of Measure: Hours
HIV seronegative Number Analyzed 56 Episodes [1]  33 Episodes [1] 
13
(7 to 73)
7
(6 to 13)
HIV seropositive Number Analyzed 20 Episodes [2]  17 Episodes [2] 
6
(5 to 126)
8
(6 to 426)
[1]
23 participants
[2]
15 participants
Time Frame Adverse event data was collected during the 9 week study period.
Adverse Event Reporting Description Adverse event data is reported only for 38 participants who completed both arms the trial.
 
Arm/Group Title No Medication Acyclovir 400 mg Twice Daily
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
No Medication Acyclovir 400 mg Twice Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
No Medication Acyclovir 400 mg Twice Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/38 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
No Medication Acyclovir 400 mg Twice Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/38 (0.00%) 
The study was performed at a single site and enrolled a mostly white population. Whether these results are generalizable to other populations is not known.
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: NCT00723229     History of Changes
Other Study ID Numbers: 34187-B
U19AI031448 ( U.S. NIH Grant/Contract )
First Submitted: July 23, 2008
First Posted: July 28, 2008
Results First Submitted: March 23, 2012
Results First Posted: March 9, 2017
Last Update Posted: March 9, 2017