Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 1 Infection
Status:
Recruiting
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
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.