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

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ClinicalTrials.gov Identifier: NCT00735761
Recruitment Status : Completed
First Posted : August 15, 2008
Last Update Posted : August 15, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Herpes Labialis Drug: ME-609 Drug: Acyclovir in ME-609 vehicle (5% acyclovir) Phase 3

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  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00735761


Sponsors and Collaborators
Medivir
Investigators
Principal Investigator: Anders Sönnerborg, MD PhD Prof. Clinical Virology, F68, Karolinska University Hospital, Huddinge, 141 86 Stockholm, Sweden

Responsible Party: Börje Darpö, MD, PhD, Development
ClinicalTrials.gov Identifier: NCT00735761     History of Changes
Other Study ID Numbers: 609-06
First Posted: August 15, 2008    Key Record Dates
Last Update Posted: August 15, 2008
Last Verified: August 2008

Additional relevant MeSH terms:
Herpes Simplex
Herpes Labialis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Acyclovir
Hydrocortisone
Antiviral Agents
Anti-Infective Agents
Anti-Inflammatory Agents