Back to resultsStudy of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis in Immunocompromised Patients
Primary Purpose
Herpes Labialis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ME-609
Acyclovir in ME-609 vehicle (5% acyclovir)
Sponsored by
About this trial
This is an interventional treatment trial for Herpes Labialis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
ME-609 (5% acyclovir and 1% hydrocortisone)
Acyclovir in ME-609 vehicle (5% acyclovir)
Outcomes
Primary Outcome 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).
Secondary Outcome 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00735761
Brief Title
Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis in Immunocompromised Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medivir
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Labialis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
ME-609 (5% acyclovir and 1% hydrocortisone)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Acyclovir in ME-609 vehicle (5% acyclovir)
Intervention Type
Drug
Intervention Name(s)
ME-609
Intervention Description
Dosage form: Cream Dose and regimen: 5 times daily during 5 days Route of administration: Topical application
Intervention Type
Drug
Intervention Name(s)
Acyclovir in ME-609 vehicle (5% acyclovir)
Intervention Description
Dosage form: Cream Dose and regimen: 5 times daily during 5 days Route of administration: Topical application
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Sönnerborg, MD PhD Prof.
Organizational Affiliation
Clinical Virology, F68, Karolinska University Hospital, Huddinge, 141 86 Stockholm, Sweden
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis in Immunocompromised Patients
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