Herpes LabialisPhase 3NCT00735761
Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis in Immunocompromised Patients
A Phase 3 study testing ME-609 in people with Herpes Labialis, run by Medivir.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Labialis
- What is being tested?
- ME-609
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Sep 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Herpes Labialis
- Being tested
- ME-609, Acyclovir in ME-609 vehicle (5% acyclovir)
- Medical subject headings
- Herpes Labialis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ME-609Drug
Dosage form: Cream Dose and regimen: 5 times daily during 5 days Route of administration: Topical application
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ME-609 (5% acyclovir and 1% hydrocortisone) Receives: Drug: ME-609 |
| 2 | Active comparator | Acyclovir in ME-609 vehicle (5% acyclovir) Receives: Drug: Acyclovir in ME-609 vehicle (5% acyclovir) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Start of recurrence until start of next recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startDec 2006
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes LabialisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medivir
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Anders Sönnerborg, MD PhD Prof., Principal investigator, Clinical Virology, F68, Karolinska University Hospital, Huddinge, 141 86 Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735761
- Sponsor's protocol ID
- 609-06
- Status last verified
- Aug 2008
- First submitted
- 14 Aug 2008
- Last updated
- 15 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00735761
- Acronym / sponsor ID
- 609-06
- Conditions
- Herpes Labialis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- MedivirIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 15 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ME-609ME-609 (5% acyclovir and 1% hydrocortisone) |
| 2 | Active comparator | Drug: Acyclovir in ME-609 vehicle (5% acyclovir)Acyclovir in ME-609 vehicle (5% acyclovir) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ME-609Dosage form: Cream Dose and regimen: 5 times daily during 5 days Route of administration: Topical application | Drug | 1 |
| Acyclovir in ME-609 vehicle (5% acyclovir)Dosage form: Cream Dose and regimen: 5 times daily during 5 days Route of administration: Topical application | Drug | 2 |
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).
Time frame: from start of treatment until loss of hard crust
1 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.
Time frame: Start of recurrence until start of next recurrence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2008.
Related trials for Herpes Labialis
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Sönnerborg, MD PhD Prof. principal investigator
Clinical Virology, F68, Karolinska University Hospital, Huddinge, 141 86 Stockholm, Sweden
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ME-609 in people with Herpes Labialis, run by Medivir.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: from start of treatment until loss of hard crust). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2008.