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

Phase 3

Completed

• Conditions: Herpes Labialis
• Interventions: Drug: Acyclovir in ME-609 vehicle (5% acyclovir); Drug: ME-609

• Registration Number: NCT00735761
• Lead Sponsor: Medivir

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2008-08
• Study First Submitted: 2008-08-14
• Study First Submitted QC: 2008-08-14
• Last Update Submitted: 2008-08-14
• Study First Posted: 2008-08-15
• Last Update Posted: 2008-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Acyclovir in ME-609 vehicle (5% acyclovir)	Acyclovir in ME-609 vehicle (5% acyclovir)
1	ME-609	ME-609 (5% acyclovir and 1% hydrocortisone)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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