Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis in Immunocompromised Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the episode duration of a herpes labialis recurrence in immunocompromised patients treated with ME-609 or Acyclovir.

Detailed Description
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The objective of this study was to evaluate the episode duration of a herpes labialis recurrence, following a 5-day treatment with 5-time daily topical administration of ME-609 or acyclovir cream, in immunocompromised adults, 18 years and older. This interim report summarizes the results for short-term observations, i.e., during the initial study recurrence. A final study report will be prepared when the long-term follow-up is completed.

Official Title
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A Randomized, Double-Blind, Active-Controlled, Subject Initiated Study Comparing ME-609 to Acyclovir Cream for Treatment of Recurrent Herpes Simplex Labialis in Immunocompromised Patients

Conditions
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Herpes Labialis

Intervention / Treatment
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* Drug: ME-609
* Drug: Acyclovir in ME-609 vehicle (5% acyclovir)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of recurrent herpes labialis with at least two recurrences during the twelve months prior to the study. Stable HIV infection CD4+ T-cell count 100 to 500/mm3 Exclusion Criteria: Systemic treatment with other antiviral agent or corticosteroids within two weeks prior to and during the treatment period, except for antiretroviral treatment in HIV subjects Topical treatment with other antiviral agent or corticosteroids within in or around the oral area within two weeks prior to study drug administration Significant skin condition that occur in the area typically affected by herpes recurrences Nursing or pregnancy Concurrent cancer therapy

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ME-609 (5% acyclovir and 1% hydrocortisone) | Drug: ME-609<br>* Dosage form: Cream Dose and regimen: 5 times daily during 5 days Route of administration: Topical application<br>|
| Active Comparator: 2<br>Acyclovir in ME-609 vehicle (5% acyclovir) | Drug: Acyclovir in ME-609 vehicle (5% acyclovir)<br>* Dosage form: Cream Dose and regimen: 5 times daily during 5 days Route of administration: Topical application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary variable was episode duration, measured from the start of treatment until loss of hard crust for an ulcerative recurrence and from the start of treatment to time of no signs or symptoms for a non-ulcerative recurrence (Investigator-assessed). |  | from start of treatment until loss of hard crust | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary variable was the time to next recurrence measured from the start of the study recurrence until the start of the next recurrence. |  | Start of recurrence until start of next recurrence |