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

NCT00735761 | Completed Phase 3

• 1 other identifier: 609-06
• Study Type: interventional
• Target: 201
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Herpes Labialis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

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

Drug: ME-609

2

ACTIVE COMPARATOR

Acyclovir in ME-609 vehicle (5% acyclovir)

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

Interventions

ME-609 DRUG

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

1

Acyclovir in ME-609 vehicle (5% acyclovir) DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medivir: lead

MeSH Terms

Conditions

Herpes Labialis

Interventions

ME 609; Acyclovir

Condition Hierarchy (Ancestors)

Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Anders Sönnerborg, MD PhD Prof.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 15, 2008
• Study Start: December 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: August 15, 2008

Record last verified: 2008-08