Try our beta test site

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

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Christine Johnston, University of Washington
ClinicalTrials.gov Identifier:
NCT00723229
First received: July 23, 2008
Last updated: March 6, 2017
Last verified: March 2017
Results First Received: March 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Genital Herpes
Intervention: Drug: acyclovir

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
No Medication First, Then Standard-dose Acyclovir No medication for 4 weeks, then 1 week washout, followed by acyclovir 400 mg twice daily for 4 weeks
Acyclovir 400 mg Twice Daily First, Followed by no Medication Acyclovir 400 mg twice daily for 4 weeks, then 1 week washout, followed by no medication for 4 weeks

Participant Flow for 2 periods

Period 1:   First Intervention
    No Medication First, Then Standard-dose Acyclovir   Acyclovir 400 mg Twice Daily First, Followed by no Medication
STARTED   25   23 
COMPLETED   18   20 
NOT COMPLETED   7   3 
Lost to Follow-up                7                3 

Period 2:   Second Intervention
    No Medication First, Then Standard-dose Acyclovir   Acyclovir 400 mg Twice Daily First, Followed by no Medication
STARTED   18   20 
COMPLETED   18   20 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

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
No Medication No text entered.
Acyclovir 400 mg Twice Daily No text entered.
Total Total of all reporting groups

Baseline Measures
   No Medication   Acyclovir 400 mg Twice Daily   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   23   48 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.6  (12.3)   42.1  (13.1)   44.4  (12.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      10  40.0%      10  43.5%      20  41.7% 
Male      15  60.0%      13  56.5%      28  58.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
HIV seropositive   9   7   16 
HIV seronegative   16   16   32 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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.   [ Time Frame: 9 weeks ]

2.  Secondary:   Quantity of HSV Detected, Median   [ Time Frame: 9 weeks ]

3.  Secondary:   Number of Genital HSV Shedding Episodes   [ Time Frame: 9 weeks ]

4.  Secondary:   Duration of Genital HSV Shedding Episodes   [ Time Frame: 9 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
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.


  More Information
  Hide More Information

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
e-mail: cjohnsto@u.washington.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Christine Johnston, University of Washington
ClinicalTrials.gov Identifier: NCT00723229     History of Changes
Other Study ID Numbers: 34187-B
U19AI031448 ( US NIH Grant/Contract Award Number )
Study First Received: July 23, 2008
Results First Received: March 23, 2012
Last Updated: March 6, 2017