HSV-2 Shedding Resolution After Acyclovir Treatment

University of Washington

Status: Completed

Conditions: Genital Herpes

Treatments: Drug: acyclovir

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00495573

R01AI050132 (U.S. NIH Grant/Contract)

P01AI030731 (U.S. NIH Grant/Contract)

26224-A

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

36 participants in 2 patient groups

1

Description:

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

Treatment:

Drug: acyclovir

2

Description:

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