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

NCT ID: NCT00735761

Last Updated: 2008-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-09-30

Brief Summary

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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

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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.

Conditions

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Herpes Labialis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

ME-609 (5% acyclovir and 1% hydrocortisone)

Group Type EXPERIMENTAL

ME-609

Intervention Type DRUG

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

2

Acyclovir in ME-609 vehicle (5% acyclovir)

Group Type ACTIVE_COMPARATOR

Acyclovir in ME-609 vehicle (5% acyclovir)

Intervention Type DRUG

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

Interventions

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ME-609

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medivir

INDUSTRY

Sponsor Role lead

Responsible Party

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Development

Principal Investigators

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Anders Sönnerborg, MD PhD Prof.

Role: PRINCIPAL_INVESTIGATOR

Clinical Virology, F68, Karolinska University Hospital, Huddinge, 141 86 Stockholm, Sweden

Other Identifiers

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609-06

Identifier Type: -

Identifier Source: org_study_id