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

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

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.

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.

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