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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00723229
First Posted: July 28, 2008
Last Update Posted: March 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Christine Johnston, University of Washington
  Purpose
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.

Condition Intervention Phase
Genital Herpes Drug: acyclovir Phase 4

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

Resource links provided by NLM:


Further study details as provided by Christine Johnston, University of Washington:

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. [ Time Frame: 9 weeks ]

Secondary Outcome 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


Enrollment: 48
Study Start Date: August 2008
Study Completion Date: September 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: acyclovir
Acyclovir 400 mg PO BID for 28 days
No Intervention: 2

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00723229


Locations
United States, Washington
University of Washington Virology Research Clinic
Seattle, Washington, United States, 98122
Sponsors and Collaborators
University of Washington
National Institutes of Health (NIH)
Investigators
Principal Investigator: Christine Johnston, MD, MPH University of Washington
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christine Johnston, Principal Investigator, 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
Last Update Posted: March 9, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Herpes Genitalis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Acyclovir
Antiviral Agents
Anti-Infective Agents