CompletedPhase 2

Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 2 Infection

Germany122 participantsStarted 2019-11-15

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years at the time of signing informed consent.
✓. Signed informed consent for participation in the study.
✓. Understanding, ability, and willingness to fully comply with study interventions and restrictions.
✓. Seropositive for HSV-2.
✓. History of chronic recurrent anogenital HSV-2 infection with ≥ 4 outbreaks (≥ 2 under standard suppressive antiviral therapy) in the last year with no active lesion at time of enrolment. Patients with acute lesion(s) can be enrolled when the previous lesion is healed off.
✓. No use of any HSV-suppressant therapy (both approved drugs and non-approved drugs including OTC drugs) including topical applications at least 7 days prior to enrolment.
✓. Willingness to not use any topical or systemic anti-HSV therapy (both approved drugs and non-approved drugs including OTC) during the study apart from the study medication.
✓. Willingness to not use any topical HSV treatment upon lesion development as well as avoid any manipulation or physical impact, e.g., cooling of the lesion particularly in the prodromal stage.

Exclusion criteria

What they're measuring

Percentage of days with lesion(s) per treatment group

Timeframe: 180 days

Trial details

NCT IDNCT04165122

SponsorHeidelberg ImmunoTherapeutics GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-08-25

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