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A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation
This study is currently recruiting participants.
Verified by University of Washington, August 2008
Sponsors and Collaborators: University of Washington
National Institutes of Health (NIH)
Information provided by: University of Washington
ClinicalTrials.gov Identifier: NCT00723229
  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 IV

MedlinePlus related topics: Herpes Simplex
Drug Information available for: Acyclovir Acyclovir sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Efficacy Study
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

Further study details as provided by 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 sero-negative AND HIV seropositive individuals. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator Drug: acyclovir
Acyclovir 400 mg PO BID for 28 days
2: No Intervention

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00723229

Contacts
Contact: Christine Johnston, MD, MPH 206-720-4340 cjohnsto@u.washington.edu

Locations
United States, Washington
University of Washington Virology Research Clinic Recruiting
Seattle, Washington, United States, 98122
Contact: Christine Johnston, MD, MPH     206-720-4340     cjohnsto@u.washington.edu    
Principal Investigator: Christine Johnston, MD, MPH            
Sponsors and Collaborators
University of Washington
National Institutes of Health (NIH)
Investigators
Principal Investigator: Christine Johnston, MD, MPH University of Washington
  More Information

Responsible Party: University of Washington ( Christine Johnston, MD, MPH )
Study ID Numbers: 34187
Study First Received: July 23, 2008
Last Updated: August 6, 2008
ClinicalTrials.gov Identifier: NCT00723229  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Genital Diseases, Female
Virus Diseases
Herpes Simplex
Sexually Transmitted Diseases, Viral
Acyclovir
 Herpes Genitalis
Sexually Transmitted Diseases
DNA Virus Infections
Genital Diseases, Male
Herpesviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009



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