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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00735761

Enrollment

201

Registered

2008-08-15

Start date

2006-12-31

Completion date

2007-09-30

Last updated

2008-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Labialis

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.

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.

Interventions

DRUGME-609

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

DRUGAcyclovir in ME-609 vehicle (5% acyclovir)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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).	from start of treatment until loss of hard crust

Secondary

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.	Start of recurrence until start of next recurrence

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026