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

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medivir
• Treatments: Acyclovir; Hydrocortisone

Criteria

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