Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2007

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.

Intervention(s) in this Clinical Trial

• Drug: ME-609
  • Dosage form: Cream Dose and regimen: 5 times daily during 5 days Route of administration: Topical application
• Drug: Acyclovir in ME-609 vehicle (5% acyclovir)
  • Dosage form: Cream Dose and regimen: 5 times daily during 5 days Route of administration: Topical application

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • ME-609 (5% acyclovir and 1% hydrocortisone)
• Active Comparator: 2
  • Acyclovir in ME-609 vehicle (5% acyclovir)

Primary Measures

• 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).
  • Time Frame: from start of treatment until loss of hard crust
    Safety Issue?: Yes

Secondary Measures

• The secondary variable was the time to next recurrence measured from the start of the study recurrence until the start of the next recurrence.
  • Time Frame: Start of recurrence until start of next recurrence
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Medivir

Overall Clinical Trial Officials and Contacts

Anders Sönnerborg, MD PhD Prof. Principal Investigator Clinical Virology, F68, Karolinska University Hospital, Huddinge, 141 86 Stockholm, Sweden  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00735761

Study ID Number: 609-06

ClinicalTrials.gov Identifier: NCT00735761

Health Authority: Russia: Ministry of Health and Social Development of the Russian Federation