A Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection In HIV-Infected Persons

Study Overview
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Brief Summary
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This clinical research study will be an international trial evaluating the safety and effectiveness of a marketed drug compared to placebo (like a sugar pill) for the suppression of repeated genital herpes infections in HIV-infected subjects with CD4+ count <100 cells/mm3.

Official Title
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An International, Randomized, Double-Blind, Placebo-Controlled Study of Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons With CD4+ Lymphocyte Count <100 Cells/mm3.

Conditions
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Herpes Genitalis

Intervention / Treatment
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* Drug: valacyclovir hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CD4+ lymphocyte count <100cells/mm3 at the screening visit. Documented history of HIV infections Must have received stable, combination anti HIV drugs for at least 4 months immediately prior to participation, and per the investigator, are unlikely to require change in anti-HIV drugs during the six-month study. Laboratory confirmation of genital herpes (a positive Herpes Simplex Virus-2 antibody test). 3 or more outbreaks of genital herpes in the previous 12 months if not on genital herpes medicines currently. 3 or more outbreaks of genital herpes per year in the period prior to beginning of treatment for chronic genital herpes. Exclusion Criteria: Kidney diseases. Liver diseases. Known allergic reactions to VALTREX (valaciclovir), ZOVIRAX (acyclovir), FAMVIR (famciclovir), or CYTOVENE (ganciclovir). Vomiting syndrome. Must be willing to discontinue taking current genital herpes medicines 1 week prior to participation. Active AIDS-indicator conditions, as defined by CDC Category C. Other protocol inclusion and exclusion criteria to be evaluated by the research physician.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suppressive + Episodic Therapy<br>Valaciclovir (VAL) 500mg twice daily for 6 months, and episodic treatment with VAL 1000mg twice daily for 5 days or 10 days, when required for treatment of a genital herpes recurrence. | Drug: valacyclovir hydrochloride<br>* valacyclovir hydrochloride<br>|
| Placebo Comparator: Episodic Therapy<br>Matching placebo twice daily for 6 months, and episodic treatment with VAL 1000mg twice daily for 5 or 10 days, when required for treatment of a genital herpes recurrence. | Drug: valacyclovir hydrochloride<br>* valacyclovir hydrochloride<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | The nature and incidence of adverse events, by treatment group, reported during the 6-month study will be summarized. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of recurrence of genital HSV | Secondary outcome measures are the proportion of subjects recurrence-free of genital HSV at 6 months, and the time to first culture-positive recurrence of genital HSV. | Up to 6 months | 
| Time to first culture-positive recurrence of genital HSV | Secondary outcome measures are the proportion of subjects recurrence-free of genital HSV at 6 months, and the time to first culture-positive recurrence of genital HSV. | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Herpes, Genital Herpes, HIV, HSV