Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 2 Infection
Status:
Active, not recruiting
Trial end date:
2021-09-01
Target enrollment:
Participant gender:
Summary
This is a randomized, double-blind, double-dummy study of single dose HDIT101 versus Standard
of Care Valaciclovir.
HSV-2-positive patients with at least 4 anogenital herpes lesions in the last 12 months (or
at least 2 herpes lesions with previous valaciclovir long-term therapy) can be included.
If a patients develops a anogenital Herpes lesion within 4 months after the screening visit,
the patients will be randomized in a 2:1 ratio to HDIT i.v. infusion + episodic treatment
with 500 mg Valaciclovir-placebo OR to a single HDIT placebo infusion + episodic treatment
with 500 mg Valaciclovir orally bid for 3 days.
Study duration per patient will be 180 days starting with the randomization visit. In
addition to the randomization visit, 4 visits at the site and 2 phone calls are scheduled.
At every occurence of a herpetic lesion during the study, patients are treated with
Valaciclovir/ Valaciclovir-placebo and need to present at the site twice to document start
and end date of the lesion (unscheduled visits).