HSV-2 Shedding Resolution After Acyclovir Treatment

NCT00495573 | Completed

• 3 other identifiers: 26224-AP01AI030731R01AI050132
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Genital Herpes

Outcome Measures

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.

  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.

  5 days

Study Arms (2)

1

HSV-2 seropositive subjects who will receive a 5-day course of acyclovir for treatment of a genital herpes recurrence.

Drug: acyclovir

2

HSV-2 seropositive subjects who will be observed during a genital herpes recurrence but not receive acyclovir.

Interventions

acyclovir DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age 18 years or older
• History of clinically-evident genital herpes
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Washington Virology Research Clinic

Seattle, Washington, 98104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, genital swab specimens

MeSH Terms

Conditions

Herpes Genitalis

Interventions

Acyclovir

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Anna Wald, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2007
• First Posted: July 3, 2007
• Study Start: June 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: March 1, 2012
• Last Updated: March 22, 2012

Record last verified: 2012-03

Locations

US (1)