Last updated on December 2019

Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 2 Infection


Brief description of study

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).

Detailed Study Description

In this trial, patients with chronic recurrent herpes simplex virus (HSV-2) infections (with at least 4 herpes lesions in the last 12 months or at least 2 herpes lesions with previous valaciclovir long-term therapy) can be included.

After signature of ICF and during the screening period, the patients take daily swabs of the anogenital area for 28 days to determine HSV shedding.

Patients not developing a lesion within 4 months after screening are not randomised. Patients developing a lesion within 4 months can be randomised and the treatment must be initiated within 72 Hours upon lesion occurence.

Approximately 125 patients will be randomized in a 2:1 ratio to one of the following treatment groups:

  • Arm A: single HDIT i.v. infusion applied over 1 hour at the randomization visit + episodic treatment with 500 mg Valaciclovir-placebo orally bid for 3 days.
  • Arm B: single HDIT placebo i.v. infusion applied over 1 hour at the randomization visit + episodic treatment with 500 mg Valaciclovir orally bid for 3 days.

The HDIT101/HDIT101-placebo infusion is only applied once during the trial, Valaciclovir (or corresponding placebo) has to be taken upon every occurence of another Herpes lesion.

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.

In case of developing another lesion after the randomization visit, patients take a single swab of the lesion and episodic SoC treatment with Valaciclovir/ Valaciclovir-placebo is started and documented in an electronic diary by the patient within 24 hours after development of first symptoms. Quality of life is also recorded.

In addition to this, the patients need to present at the site within 72 hours after occurence of a the new herpes outbreak for medical examination and to confirm the HSV-2 lesion. At this unscheduled visit at the site, the PI will take a second swab and assess the lesion (including start date). Another unscheduled visit will take place upon healing of lesion.

This procedure will be repeated for every outbreak during the trial.

Clinical Study Identifier: NCT04165122

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