A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation
Primary Purpose
Genital Herpes
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
acyclovir
Sponsored by
About this trial
This is an interventional treatment trial for Genital Herpes
Eligibility Criteria
Inclusion Criteria:
COHORT 1: HIV seronegative
- Older than 18 years;
- HSV-2 seropositive by Western Blot;
- not receiving any drugs with known anti-HSV-2 activity for study duration;
- women of child bearing potential who are sexually active with men must be using a medically accepted method of contraception as judged by the investigator;
- women of child-bearing potential must have a negative pregnancy test (urine) at screening visit;
- in general good health, without other serious medical conditions and specifically with normal renal and hepatic function, as determined by the patient's medical history;
- planning to remain resident in the area of the study center for the duration of the study participation;
- HIV seronegative
COHORT 2: HIV seropositive
- Older than18 years;
- HSV-2 seropositive by Western Blot;
- not receiving any drugs with known anti-HSV-2 activity for study duration;
- women of child bearing potential who are sexually active with men must be using a medically accepted method of contraception as judged by the investigator;
- women of child-bearing potential must have a negative pregnancy test (urine) at screening visit;
- in general good health, without other serious medical conditions and specifically with normal renal and hepatic function, as determined by the patient's medical history;
- planning to remain resident in the area of the study center for the duration of the study participation;
- HIV seropositive
- CD4 count over 250 cell/mm3
- Not taking antiretroviral therapy
Exclusion Criteria:
For both cohorts:
- hypersensitivity to acyclovir or valacyclovir;
- pregnant women;
- Taking immunosuppressive therapies, such as chronic oral steroids or immune modulatory drugs.
For cohort 2:
- CD4 count<250 cell/mm3
- Taking antiretroviral therapy at the time of study entry
Sites / Locations
- University of Washington Virology Research Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Quantity of HSV Detected, Median
Median quantity of HSV detected, among swabs with any HSV detected
Number of Genital HSV Shedding Episodes
The number of HSV shedding episodes. A shedding episode is defined as any number of positive swabs preceded and followed by 2 negative swabs
Duration of Genital HSV Shedding Episodes
Median duration of HSV shedding episodes, in hours
Full Information
NCT ID
NCT00723229
First Posted
July 23, 2008
Last Updated
March 6, 2017
Sponsor
University of Washington
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT00723229
Brief Title
A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation
Official Title
A Randomized, Cross-Over Study to Evaluate the Suppressive Effect of Acyclovir on Rapidly Cleared Herpes Simplex Virus Type 2 Genital Reactivation Episodes in Herpes Simplex Virus-2 Seropositive Adults
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institutes of Health (NIH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
We propose to study the episode rate, duration, and quantity of HSV-2 genital shedding in patients taking standard, FDA approved, CDC recommended doses of acyclovir (400 mg PO BID) for HSV-2 suppression compared to taking no medication to better define the effect of acyclovir on short bursts of rapidly cleared HSV-2 shedding. This study will be a randomized, open label, cross-over trial. We hypothesize that short bursts of HSV-2 reactivation will not be suppressed by acyclovir.
Detailed Description
We propose to study the episode rate, duration, and quantity of HSV-2 genital shedding in patients taking standard, FDA approved, CDC recommended doses of acyclovir (400 mg PO BID) for HSV-2 suppression compared to taking no medication to better define the effect of acyclovir on short bursts of rapidly cleared HSV-2 shedding. This study will be a randomized, open label, cross-over trial.
We propose to perform this study in two study populations. Cohort 1 will be comprised of 25 HSV-2 seropositive, HIV seronegative adults, and Cohort 2 will be comprised of 25 HSV-2 seropositive, HIV seropositive adults with a CD4 count>250 cells/mm3. As suppression of HSV-2 using acyclovir is currently being studied in large, multi-center, international clinical trials as an HIV prevention strategy, these results will have broad implications for public health around the world.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Herpes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
acyclovir
Intervention Description
Acyclovir 400 mg PO BID for 28 days
Primary Outcome Measure Information:
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.
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Quantity of HSV Detected, Median
Description
Median quantity of HSV detected, among swabs with any HSV detected
Time Frame
9 weeks
Title
Number of Genital HSV Shedding Episodes
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
Title
Duration of Genital HSV Shedding Episodes
Description
Median duration of HSV shedding episodes, in hours
Time Frame
9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COHORT 1: HIV seronegative
Older than 18 years;
HSV-2 seropositive by Western Blot;
not receiving any drugs with known anti-HSV-2 activity for study duration;
women of child bearing potential who are sexually active with men must be using a medically accepted method of contraception as judged by the investigator;
women of child-bearing potential must have a negative pregnancy test (urine) at screening visit;
in general good health, without other serious medical conditions and specifically with normal renal and hepatic function, as determined by the patient's medical history;
planning to remain resident in the area of the study center for the duration of the study participation;
HIV seronegative
COHORT 2: HIV seropositive
Older than18 years;
HSV-2 seropositive by Western Blot;
not receiving any drugs with known anti-HSV-2 activity for study duration;
women of child bearing potential who are sexually active with men must be using a medically accepted method of contraception as judged by the investigator;
women of child-bearing potential must have a negative pregnancy test (urine) at screening visit;
in general good health, without other serious medical conditions and specifically with normal renal and hepatic function, as determined by the patient's medical history;
planning to remain resident in the area of the study center for the duration of the study participation;
HIV seropositive
CD4 count over 250 cell/mm3
Not taking antiretroviral therapy
Exclusion Criteria:
For both cohorts:
hypersensitivity to acyclovir or valacyclovir;
pregnant women;
Taking immunosuppressive therapies, such as chronic oral steroids or immune modulatory drugs.
For cohort 2:
CD4 count<250 cell/mm3
Taking antiretroviral therapy at the time of study entry
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Johnston, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington Virology Research Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22225814
Citation
Johnston C, Saracino M, Kuntz S, Magaret A, Selke S, Huang ML, Schiffer JT, Koelle DM, Corey L, Wald A. Standard-dose and high-dose daily antiviral therapy for short episodes of genital HSV-2 reactivation: three randomised, open-label, cross-over trials. Lancet. 2012 Feb 18;379(9816):641-7. doi: 10.1016/S0140-6736(11)61750-9. Epub 2012 Jan 4. Erratum In: Lancet. 2012 Feb 18;379(9816):616.
Results Reference
derived
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A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation
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