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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2010

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.

Interventions

  • Drug: acyclovir
    • Acyclovir 400 mg PO BID for 28 days

Arms, Groups and Cohorts

  • Active Comparator: 1
  • No Intervention: 2

Clinical Trial Outcome Measures

Primary 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.
    • Time Frame: 9 weeks

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Washington
  • Collaborator
    • National Institutes of Health (NIH)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Christine Johnston, Principal Investigator – University of Washington
  • Overall Official(s)
    • Christine Johnston, MD, MPH, Principal Investigator, University of Washington

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