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

Information source: Medivir
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Herpes Labialis

Intervention: ME-609 (Drug); Acyclovir in ME-609 vehicle (5% acyclovir) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Medivir

Official(s) and/or principal investigator(s):
Anders Sönnerborg, MD PhD Prof., Principal Investigator, Affiliation: Clinical Virology, F68, Karolinska University Hospital, Huddinge, 141 86 Stockholm, Sweden

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.

Clinical Details

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

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

Primary outcome: 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).

Secondary outcome: The secondary variable was the time to next recurrence measured from the start of the study recurrence until the start of the next recurrence.

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: December 2006
Last updated: August 14, 2008

Page last updated: August 23, 2015

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