GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women

Conditions
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Genital Herpes

Intervention / Treatment
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* Drug: acyclovir
* Drug: matching placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: acyclovir<br> | Drug: acyclovir<br>* 400mg taken orally three times daily for 5 days<br>|
| Placebo Comparator: placebo<br> | Drug: matching placebo<br>* matching placebo taken orally three times daily for 5 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Healing of Genital Lesions | To examine time to healing of genital lesions among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo | Days 1-5, 7, 9, 11, 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Negative Herpes Simplex Virus (HSV) DNA PCR | To examine the time to first negative HSV DNA PCR among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo | Days 1-5, 7, 9, 11, 13 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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herpes simplex virus, acyclovir, HSV shedding, women, Africa