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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

Tracking Information
First Submitted Date  ICMJE July 23, 2008
First Posted Date  ICMJE July 28, 2008
Results First Submitted Date  ICMJE March 23, 2012
Results First Posted Date  ICMJE March 9, 2017
Last Update Posted Date March 9, 2017
Study Start Date  ICMJE August 2008
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2017)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 23, 2008)
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 sero-negative AND HIV seropositive individuals. [ Time Frame: 9 weeks ]
Change History Complete list of historical versions of study NCT00723229 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2017)
  • Quantity of HSV Detected, Median [ Time Frame: 9 weeks ]
    Median quantity of HSV detected, among swabs with any HSV detected
  • Number of Genital HSV Shedding Episodes [ Time Frame: 9 weeks ]
    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 [ Time Frame: 9 weeks ]
    Median duration of HSV shedding episodes, in hours
Original Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2008)
  • Frequency of subclinical shedding from the genital tract as measured by PCR, calculated using a per-day shedding rate in participants treated with with suppressive acyclovir as compared to no medication. [ Time Frame: 9 weeks ]
  • Frequency of lesional shedding from the genital tract as measured by PCR, calculated using a per day shedding rate in participants treated with with suppressive acyclovir as compared to no medication. [ Time Frame: 9 weeks ]
  • Number of herpes recurrences, defined clinically as >=1 successive day on which genital lesions are present, in participants treated with with suppressive acyclovir as compared to no medication. [ Time Frame: 9 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Genital Herpes
Intervention  ICMJE Drug: acyclovir
Acyclovir 400 mg PO BID for 28 days
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Drug: acyclovir
  • No Intervention: 2
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2017)
48
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2008)
50
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

COHORT 1: HIV seronegative

  1. Older than 18 years;
  2. HSV-2 seropositive by Western Blot;
  3. not receiving any drugs with known anti-HSV-2 activity for study duration;
  4. 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;
  5. women of child-bearing potential must have a negative pregnancy test (urine) at screening visit;
  6. 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;
  7. planning to remain resident in the area of the study center for the duration of the study participation;
  8. HIV seronegative

COHORT 2: HIV seropositive

  1. Older than18 years;
  2. HSV-2 seropositive by Western Blot;
  3. not receiving any drugs with known anti-HSV-2 activity for study duration;
  4. 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;
  5. women of child-bearing potential must have a negative pregnancy test (urine) at screening visit;
  6. 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;
  7. planning to remain resident in the area of the study center for the duration of the study participation;
  8. HIV seropositive
  9. CD4 count over 250 cell/mm3
  10. Not taking antiretroviral therapy

Exclusion Criteria:

For both cohorts:

  1. hypersensitivity to acyclovir or valacyclovir;
  2. pregnant women;
  3. Taking immunosuppressive therapies, such as chronic oral steroids or immune modulatory drugs.

For cohort 2:

  1. CD4 count<250 cell/mm3
  2. Taking antiretroviral therapy at the time of study entry
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00723229
Other Study ID Numbers  ICMJE 34187-B
U19AI031448 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christine Johnston, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Christine Johnston, MD, MPH University of Washington
PRS Account University of Washington
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP