Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 1 Infection
Stopped: stopped for futility in interim analysis
Germany761 participantsStarted 2020-10-08
Plain-language summary
This is a phase II, double-blind, randomised, controlled, multicentre trial of topical HDIT101 versus placebo. HSV-1-positive patients with at least 6 orolabial herpes lesions in the last 12 months can be included.
The patients need to present with 3 herpes lesions within a 9 months observation phase. With the occurrence of the third lesion, the patients will enter the 12 months treatment phase and will be randomized in a 2:1 ratio to topical HDIT or placebo applied over 2 days. A potential fourth lesion will also be treated with the blinded study medication and additional lesions will be documented.
In a 12 months post-trial follow-up phase, further information on the occurence of lesions will be collected 4 times by phone.
Study duration per patient will be up to 21 months plus 12 months post-trial follow-up by phone. Patients need to come for study visits up to 9 times.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Main Inclusion Criteria:
* Ability to provide written, personally signed and dated informed consent
* Age ≥ 18 years
* Understanding, ability, and willingness to fully comply with study interventions and restrictions.
* Seropositive for HSV-1 at screening with a history of chronic recurrent orolabial herpes infection for at least 12 months with at least 6 orolabial recurrences in the last year.
* Three confirmed lesions within 9 months after enrolment.
* Willingness not to use any HSV-suppressant therapy except 5% aciclovir cream as optional standard of care
* Willingness to remove beard or lip piercings if lesion boundaries in this region cannot be evaluated and topical treatment of the entire lesion is compromised (according to judgement of investigator).
* Willingness to self-obtain daily swabs from the orolabial region, to provide photos of the lesions and to complete questionnaires during the study.
* Medical assessment with no clinically significant morbidities or abnormalities as per judgement of the investigator.
* Willingness to use contraceptive methods for 30 days after each treatment.
* Availability of a mobile phone, tablet, or other smart device with a camera, connection to the internet and willingness to use this device for documentation of patient-reported outcomes and photo upload.
Main Exclusion Criteria:
* Patients who do not develop at least 3 lesions of stage 3 or higher during the 9 months observation phase or do not develop any lesion within 150 days…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary endpoint: Number of recurrences after topical HDIT101 versus placebo after 12 months.