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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 2009
First Received: July 23, 2008   Last Updated: August 31, 2009   History of Changes
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

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

Resource links provided by NLM:

MedlinePlus related topics: Herpes Simplex
Drug Information available for: Acyclovir Acyclovir sodium
U.S. FDA Resources

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

No publications provided

Responsible Party: University of Washington ( Christine Johnston, MD, MPH )
Study ID Numbers: 34187-B
Study First Received: July 23, 2008
Last Updated: August 31, 2009
ClinicalTrials.gov Identifier: NCT00723229     History of Changes
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 11, 2009



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