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

Herpes Labialis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00735761
• Other study ID #: 609-06
• Status: Completed
• Phase: Phase 3
• First received: August 14, 2008
• Last updated: August 14, 2008
• Start date: December 2006
• Est. completion date: September 2007

Study information

• Verified date: August 2008
• Source: Medivir
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian FederationUkraine: Ministry of HealthUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Labialis
• Herpes Simplex

Intervention

Drug:
• ME-609
Dosage form: Cream Dose and regimen: 5 times daily during 5 days Route of administration: Topical application
• Acyclovir in ME-609 vehicle (5% acyclovir)
Dosage form: Cream Dose and regimen: 5 times daily during 5 days Route of administration: Topical application

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medivir

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		from start of treatment until loss of hard crust	Yes
Secondary	The secondary variable was the time to next recurrence measured from the start of the study recurrence until the start of the next recurrence.		Start of recurrence until start of next recurrence	Yes