HSV-2 Shedding Resolution After Acyclovir Treatment

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Anna Wald, University of Washington
ClinicalTrials.gov Identifier:
NCT00495573
First received: June 29, 2007
Last updated: March 21, 2012
Last verified: March 2012

June 29, 2007
March 21, 2012
June 2007
November 2009   (final data collection date for primary outcome measure)
To calculate the half-life of detectable HSV-2 DNA in genital mucosa during a clinical recurrence of genital herpes, after treatment with acyclovir has begun. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00495573 on ClinicalTrials.gov Archive Site
To describe the time course, diurnal variation, and pattern of resolution of HSV-2 shedding during both acyclovir-treated and untreated clinical recurrences of genital herpes. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
HSV-2 Shedding Resolution After Acyclovir Treatment
Half-life and Pattern of Resolution of Herpes Simplex Virus Type 2 (HSV-2) Shedding After Beginning Acyclovir Treatment

The purpose of the study is to evaluate the pattern of viral shedding after beginning treatment with acyclovir for a clinical recurrence of genital herpes and to compare it with the pattern of viral shedding during an untreated clinical recurrence of genital herpes.

The purpose of the study is to evaluate the pattern of viral shedding after beginning treatment with acyclovir for a clinical recurrence of genital herpes and to compare it with the pattern of viral shedding during an untreated clinical recurrence of genital herpes.

Participants are asked to visit the University of Washington Virology Research Clinic for an initial screening appointment in which the clinician will ensure eligibility and informed consent will be obtained.

Participants who experience an outbreak during the next year will be asked to call the clinic at the beginning of their next outbreak. The clinician will arrange to admit the participant to the UW General Clinical Research Center (GCRC) for a 5-day hospitalization stay. During hospitalization, participants will take acyclovir (400mg 3 times daily) and genital swabs will be collected every 2 hours during the day and every 4 hours at night for 5 days. After the last swab has been taken, the study nurse at the GCRC will do a final genital exam and the participant will be discharged. Some participants will also be asked to enroll in a control arm during which the same procedures will be followed except they will not take acyclovir during the recurrence.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

whole blood, genital swab specimens

Non-Probability Sample

HSV-2 seropositive men and women with a history of at least 3 clinical recurrences of genital herpes within the year prior to the screening visit. Participants will be recruited from the community.

Genital Herpes
Drug: acyclovir
400 mg acyclovir, orally three times a day for 5 days
  • 1
    HSV-2 seropositive subjects who will receive a 5-day course of acyclovir for treatment of a genital herpes recurrence.
    Intervention: Drug: acyclovir
  • 2
    HSV-2 seropositive subjects who will be observed during a genital herpes recurrence but not receive acyclovir.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
March 2012
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 years or older
  • History of clinically-evident genital herpes
  • 3 or more clinical genital herpes recurrences within the prior 12 months
  • HSV-2 seropositive by HSV Western Blot
  • Willing and able to comply with study protocol

Exclusion Criteria:

  • Pregnancy
  • Taking daily antiviral therapy for genital herpes
  • HIV seropositive or known immunocompromising medical condition
  • Plan to move from the Seattle area within the next year
  • Hypersensitivity to or intolerance of acyclovir
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00495573
26224-A, P01 AI-30731, R01 AI050132
No
Anna Wald, University of Washington
University of Washington
National Institutes of Health (NIH)
Principal Investigator: Anna Wald, MD, MPH University of Washington
University of Washington
March 2012

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