Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2026-02-01 @ 10:06 AM
Study NCT ID:
NCT00735761
Status:
COMPLETED
Last Update Posted:
2008-08-15
First Post:
2008-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis in Immunocompromised Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006560', 'term': 'Herpes Labialis'}], 'ancestors': [{'id': 'D006561', 'term': 'Herpes Simplex'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D008047', 'term': 'Lip Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C558464', 'term': 'ME 609'}, {'id': 'D000212', 'term': 'Acyclovir'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-08-14', 'studyFirstSubmitDate': '2008-08-14', 'studyFirstSubmitQcDate': '2008-08-14', 'lastUpdatePostDateStruct': {'date': '2008-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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).', 'timeFrame': 'from start of treatment until loss of hard crust'}], 'secondaryOutcomes': [{'measure': 'The secondary variable was the time to next recurrence measured from the start of the study recurrence until the start of the next recurrence.', 'timeFrame': 'Start of recurrence until start of next recurrence'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Herpes Labialis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of recurrent herpes labialis with at least two recurrences during the twelve months prior to the study.\n* Stable HIV infection\n* CD4+ T-cell count 100 to 500/mm3\n\nExclusion Criteria:\n\n* 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\n* Topical treatment with other antiviral agent or corticosteroids within in or around the oral area within two weeks prior to study drug administration\n* Significant skin condition that occur in the area typically affected by herpes recurrences\n* Nursing or pregnancy\n* Concurrent cancer therapy'}, 'identificationModule': {'nctId': 'NCT00735761', 'briefTitle': 'Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis in Immunocompromised Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medivir'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '609-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'ME-609 (5% acyclovir and 1% hydrocortisone)', 'interventionNames': ['Drug: ME-609']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Acyclovir in ME-609 vehicle (5% acyclovir)', 'interventionNames': ['Drug: Acyclovir in ME-609 vehicle (5% acyclovir)']}], 'interventions': [{'name': 'ME-609', 'type': 'DRUG', 'description': 'Dosage form: Cream Dose and regimen: 5 times daily during 5 days Route of administration: Topical application', 'armGroupLabels': ['1']}, {'name': 'Acyclovir in ME-609 vehicle (5% acyclovir)', 'type': 'DRUG', 'description': 'Dosage form: Cream Dose and regimen: 5 times daily during 5 days Route of administration: Topical application', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Anders Sönnerborg, MD PhD Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Virology, F68, Karolinska University Hospital, Huddinge, 141 86 Stockholm, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medivir', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Börje Darpö, MD, PhD', 'oldOrganization': 'Development'}}}}