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Completed

NCT Number: NCT00735761

Study of ME-609 and Acyclovir for Treatment of 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.

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Key information

Conditions

Herpes Labialis DNA Virus Infections Herpes Simplex Herpesviridae Infections Infections Lip Diseases Mouth Diseases Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Stomatognathic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ME-609

Drug

Dosage form: Cream Dose and regimen: 5 times daily during 5 days Route of administration: Topical application

Acyclovir in ME-609 vehicle (5% acyclovir)

Drug

Dosage form: Cream Dose and regimen: 5 times daily during 5 days Route of administration: Topical application

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medivir

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Aug 15, 2008
Registry last updated
Aug 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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