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OpenTrials
Completed

NCT Number: NCT00495573

HSV-2 Shedding Resolution After 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acyclovir

Drug

400 mg acyclovir, orally three times a day for 5 days

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Half-life and Pattern of Resolution of Herpes Simplex Virus Type 2 (HSV-2) Shedding After Beginning Acyclovir Treatment

Important dates

Study start
2007
Primary completion
2009
Study completion
2012
First posted
Jul 3, 2007
Registry last updated
Mar 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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