Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 2 Infection (MATCH-2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04165122|
Recruitment Status : Completed
First Posted : November 15, 2019
Last Update Posted : January 18, 2022
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).
|Condition or disease||Intervention/treatment||Phase|
|Herpes Genitalis||Biological: HDIT101 Drug: Valaciclovir Biological: HDIT101 placebo Drug: Valaciclovir placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, Double-Blind, Double-Dummy|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Block randomisation|
|Official Title:||A Randomized, Double-Blind, Double-Dummy Phase II Study of Single Dose HDIT101 Versus Standard of Care Valaciclovir in Patients With Chronic Recurrent Anogenital HSV-2 Infection|
|Actual Study Start Date :||November 15, 2019|
|Actual Primary Completion Date :||August 25, 2021|
|Actual Study Completion Date :||November 1, 2021|
Experimental: HDIT101 + Valaciclovir placebo
Patients treated with a single i.v. infusion of 2 g HDIT101 for 60 min at the randomization visit and with an episodic Valaciclovir placebo bid for 3 days.
Drug: Valaciclovir placebo
oral application of encapsulated Valaciclovir placebo tablets
Active Comparator: HDIT101 placebo + Valaciclovir
Patients treated with a single i.v. infusion of HDIT101 placebo for 60 min at the randomization visit and with episodic Valaciclovir 500 mg twice daily for 3 days.
oral application of encapsulated Valaciclovir tablets
Other Name: Valtrex
Biological: HDIT101 placebo
- Percentage of days with lesion(s) per treatment group [ Time Frame: 180 days ]Primary objective is calculated as the number of days with lesion (except the lesion episode at randomization) divided by the number of study days after IMP infusion.
- Time to first recurrence of lesion [ Time Frame: 180 days ]Time to first recurrence of lesion as reported by patient and verified by investigator
- Recurrence rate of lesions [ Time Frame: 180 days ]Recurrence rate is defined as number of recurrences divided by the total number of study days after IMP infusion
- Duration of recurrent lesions [ Time Frame: 180 days ]Duration of recurrent lesions is calculated as consecutive days with lesions of HSV score 2-7
- Disease-specific symptoms [ Time Frame: 180 days ]Disease-specific symptoms assessed by Herpes Symptoms Checklist
- Herpes outbreak impact [ Time Frame: 180 days ]Herpes outbreak impact assessed by Herpes Outbreak Impact Questionnaire
- QoL [ Time Frame: 180 days ]Change in QoL between baseline and EoS assessed by the Recurrent Genital Herpes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04165122
|Berlin, Germany, 10629|
|Berlin, Germany, 10777|
|WIR "Walk In Ruhr" im St. Elisabeth Hospital|
|Bochum, Germany, 44787|
|Infektio Research GmbH & Co. KG|
|Frankfurt, Germany, 60596|
|Universitätsklinikum Freiburg, Medizin II, Infektiologie|
|Freiburg, Germany, 79106|
|Hamburg, Germany, 20146|
|Dr. Scholten und Schneeweiß GbR|
|Koeln, Germany, 50674|
|Muenchen, Germany, 80336|
|Study Director:||Stefan Schoeffel||Heidelberg ImmunoTherapeutics GmbH|