Status:
COMPLETED
Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis in Immunocompromised Patients
Lead Sponsor:
Medivir
Conditions:
Herpes Labialis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT00735761
Start Date
December 1 2006
End Date
September 1 2007
Last Update
August 15 2008
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