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

August 14, 2008 updated by: Medivir

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

201

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
ME-609 (5% acyclovir and 1% hydrocortisone)
Drug: ME-609
Dosage form: Cream Dose and regimen: 5 times daily during 5 days Route of administration: Topical application
Active Comparator: 2
Acyclovir in ME-609 vehicle (5% acyclovir)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
from start of treatment until loss of hard crust

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Start of recurrence until start of next recurrence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medivir

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

August 14, 2008

First Submitted That Met QC Criteria

August 14, 2008

First Posted (Estimate)

August 15, 2008

Study Record Updates

Last Update Posted (Estimate)

August 15, 2008

Last Update Submitted That Met QC Criteria

August 14, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 609-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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