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

Medivir

Status and phase

Completed

Phase 3

Conditions

Herpes Labialis

Treatments

Drug: ME-609

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00735761

609-06

Details and patient eligibility

About

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.

Full 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.

Enrollment

201 patients

Sex

All

Ages

18+ years old

Volunteers

No 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