GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women (PK/GUD)

University of Washington

Status: Completed

Conditions: Genital Herpes

Treatments: Drug: matching placebo; Drug: acyclovir

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00808405

U01AI052054 (U.S. NIH Grant/Contract)

34708-A

Details and patient eligibility

About

To examine the time to healing of genital lesion and duration of herpes simplex virus (HSV) shedding from genetic ulcer disease (GUD) among 90 HIV-negative African women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative randomized in a 2:1 ratio to receive episodic acyclovir 400mg orally three times daily or matching placebo three times daily for 5 days and who are followed for a total of 13 days.

Enrollment: 88 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• HIV negative as determined by concordant rapid testing
• HSV-2 seropositive (Focus HerpeSelect >3.4)
• At least one prior occurrence of GUD
• 18-50 years of age

Exclusion criteria

• Current use, or use w/in past 7 days of acyclovir, valacyclovir, or famciclovir
• Prior hypersensitivity &/or allergic reaction to acyclovir
• Use of probenicid
• Current use, or use within past 28 days, of an investigational agent
• Currently pregnant or nursing
• Currently plan to become pregnant during next 3 months
• Any condition that will interfere with successful completion of study procedures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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88 participants in 2 patient groups, including a placebo group

acyclovir

Active Comparator group

Treatment:

Drug: acyclovir

placebo

Placebo Comparator group

Treatment:

Drug: matching placebo