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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:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Christine Johnston, University of Washington
ClinicalTrials.gov Identifier:
NCT00723229
First received: July 23, 2008
Last updated: March 6, 2017
Last verified: March 2017
July 23, 2008
March 6, 2017
August 2008
July 2010   (Final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00723229 on ClinicalTrials.gov Archive Site
  • 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
  • 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 ]
Not Provided
Not Provided
 
A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation
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
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Treatment
Genital Herpes
Drug: acyclovir
Acyclovir 400 mg PO BID for 28 days
  • Active Comparator: 1
    Intervention: Drug: acyclovir
  • No Intervention: 2
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.
 
Completed
48
September 2011
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00723229
34187-B
U19AI031448 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Christine Johnston, University of Washington
University of Washington
National Institutes of Health (NIH)
Principal Investigator: Christine Johnston, MD, MPH University of Washington
University of Washington
March 2017

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