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

This study has been completed.
Sponsor:
Information provided by:
Medivir
ClinicalTrials.gov Identifier:
NCT00735761
First received: August 14, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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 Intervention Phase
Herpes Labialis
Drug: ME-609
Drug: Acyclovir in ME-609 vehicle (5% acyclovir)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Medivir:

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). [ Time Frame: from start of treatment until loss of hard crust ] [ Designated as safety issue: Yes ]

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. [ Time Frame: Start of recurrence until start of next recurrence ] [ Designated as safety issue: Yes ]

Enrollment: 201
Study Start Date: December 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735761

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

No publications provided

Responsible Party: Börje Darpö, MD, PhD, Development
ClinicalTrials.gov Identifier: NCT00735761     History of Changes
Other Study ID Numbers: 609-06
Study First Received: August 14, 2008
Last Updated: August 14, 2008
Health Authority: Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 29, 2014