Ongoing Clinical Trials for Herpes Simplex
There are currently 4 clinical trials investigating new treatments for herpes simplex infections. These studies are taking place across several European countries and focus on different aspects of the disease, from serious lung infections in intensive care patients to recurrent cold sores and genital herpes. The trials are testing various antiviral medications and immunotherapies to improve treatment options for patients.
Clinical trial locations
- Belgium
- Study on Pritelivir for Treating Acyclovir-Resistant Herpes Simplex Virus in Immunocompromised Patients
- Study on the Effectiveness of 2LHERP in Reducing Recurrent Cold Sores in Patients with Frequent Outbreaks
- Study of HSV immunotherapy (HSVTI) for healthy adults aged 18-40 and people with recurrent genital herpes aged 18-60
- Estonia
- France
- Germany
- Study on Pritelivir for Treating Acyclovir-Resistant Herpes Simplex Virus in Immunocompromised Patients
- Study on the Effect of Acyclovir in ICU Patients with Pneumonia and Herpes Simplex Virus Type 1 Detected in Lung Fluid
- Study of HSV immunotherapy (HSVTI) for healthy adults aged 18-40 and people with recurrent genital herpes aged 18-60
- Greece
- Italy
- Spain
Study on the Effect of Acyclovir in ICU Patients with Pneumonia and Herpes Simplex Virus Type 1 Detected in Lung Fluid
This trial is taking place in Germany and focuses on a specific group of critically ill patients who are in intensive care units. It aims to understand whether the antiviral medication acyclovir can help patients who have pneumonia and also have the herpes simplex virus type 1 detected in their lungs.
Who can join: To participate, you must be at least 18 years old and require breathing support from a machine or other assistance. You must have pneumonia, which is a lung infection, and a test must show that you have at least 1,000 copies per milliliter of herpes simplex virus type 1 in your lungs. Either you or your legal representative must provide consent to participate in the study.
Who cannot join: You cannot participate if you are not in an intensive care unit, not on a ventilator, do not have pneumonia, or do not have the virus detected in your lung fluid.
What the study is testing: The trial is investigating whether acyclovir, given through an infusion into the bloodstream, can improve survival rates and health outcomes for these critically ill patients. The main goal is to see if the treatment reduces the 30-day mortality rate. Researchers will also monitor how many days patients can breathe without machine support, how long they stay in the hospital, and their overall quality of life during and after treatment.
Medication being tested: Acyclovir is the main drug being studied. It is a well-known antiviral medication that works by preventing the virus from multiplying in the body.
Study on the Effectiveness of 2LHERP in Reducing Recurrent Cold Sores in Patients with Frequent Outbreaks
This trial is being conducted in Belgium and focuses on people who experience frequent cold sores around the mouth and face. The study aims to determine whether a treatment called 2LHERP can reduce the number of outbreaks over time.
Who can join: You can participate if you are between 16 and 80 years old and have experienced 6 or more episodes of cold sores in the past 12 months. If you are a woman of childbearing age, you must use effective birth control. You should also have a stable sexual relationship, be able to understand the study requirements, and sign an informed consent form.
Who cannot join: The trial excludes patients who have had 6 or more episodes of cold sores in the 12 months before the study, though this appears to be a documentation inconsistency as this is actually an inclusion criterion.
What the study is testing: The trial will evaluate whether 2LHERP granules, taken by mouth, can decrease the frequency of cold sore outbreaks over a 12-month period. The study will compare results between those receiving the actual treatment and those receiving a placebo. Researchers will also track the time until the first recurrence, the duration of episodes, pain levels, and quality of life.
Medication being tested: 2LHERP is an investigational treatment containing specific nucleic acids designed to help manage recurrent cold sores.
Study of HSV immunotherapy (HSVTI) for healthy adults aged 18-40 and people with recurrent genital herpes aged 18-60
This study is taking place in Germany, Spain, Belgium, and Estonia. It investigates a new immunotherapy approach designed to help the body’s immune system fight against herpes simplex virus infections. The trial includes both healthy volunteers and people who experience recurring genital herpes.
Who can join: The study has two parts. For Part I, you must be a healthy person between 18 and 40 years old who tests negative for HSV-2. For Part II, you must be between 18 and 60 years old, test positive for HSV-2, have had genital herpes for at least one year, and have experienced 3 to 9 outbreaks in the past 12 months. All participants must be willing to follow study requirements, including keeping electronic diaries and attending follow-up visits. Women who can become pregnant must use effective birth control and have negative pregnancy tests. All participants must test negative for HIV.
Who cannot join: You cannot participate if you are under 18 or over 65 years old, have a weakened immune system, received any vaccine within 30 days before the study, are pregnant or breastfeeding, have severe allergic reactions to vaccines, have active autoimmune disease, use medications that affect the immune system, have had cancer within the past 5 years, have severe uncontrolled chronic conditions, have blood disorders, have active infections requiring treatment, or have a history of drug or alcohol abuse within the past year.
What the study is testing: The trial evaluates the safety and effectiveness of HSVTI, a targeted immunotherapy given as an intramuscular injection. The main goals are to assess how well people tolerate the treatment, measure the immune system response, and determine if it can reduce the frequency of genital herpes outbreaks. Participants will receive multiple doses and will be monitored for side effects at the injection site and throughout the body.
Medication being tested: HSVTI is an investigational therapeutic vaccine that aims to stimulate the immune system to recognize and fight the herpes virus, potentially reducing outbreak frequency and severity.
Study on Pritelivir for Treating Acyclovir-Resistant Herpes Simplex Virus in Immunocompromised Patients
This trial is being conducted across multiple countries including Greece, Germany, France, Italy, and Belgium. It focuses on a particularly challenging situation: treating herpes infections that no longer respond to standard antiviral medications in people with weakened immune systems.
Who can join: You can participate if you are immunocompromised, meaning your immune system is weakened due to conditions like HIV infection, organ transplants, or long-term use of medications that suppress the immune system. You must be at least 16 years old, though in some countries like Canada, Germany, and Belgium, you must be at least 18. You must have a herpes infection that does not respond to acyclovir treatment, and the sores must be in a location where a doctor can easily see and check them. You must agree to use highly effective birth control methods during the study and provide written consent. Women who can become pregnant must have negative pregnancy tests before starting.
Who cannot join: You cannot participate if you do not have a weakened immune system, do not have acyclovir-resistant herpes infections, or do not meet the specific age and health criteria set by the study.
What the study is testing: The trial evaluates whether pritelivir, taken as an oral tablet once daily for up to 28 days, can effectively treat herpes infections that are resistant to standard treatments. The study will monitor healing of lesions, recurrence of the virus, and any side effects. Researchers will compare pritelivir to other treatments chosen by the investigator, including foscarnet and other antiviral medications. Follow-up assessments will occur at 1, 2, and 3 months after treatment ends.
Medications being tested: The main drug being studied is pritelivir, which works differently from acyclovir by inhibiting a viral enzyme essential for viral DNA replication. The trial also includes comparison with foscarnet and other antiviral medications used when standard treatments fail.
Summary
These four clinical trials represent diverse approaches to managing different aspects of herpes simplex infections. The studies are concentrated primarily in Belgium and Germany, with additional sites in Spain, Estonia, France, Greece, and Italy, reflecting strong European involvement in herpes research.
The trials address a spectrum of clinical situations, from life-threatening lung infections in intensive care patients to quality-of-life issues related to recurrent cold sores and genital herpes. Notably, two trials focus on situations where standard treatments have failed: one examining pritelivir for acyclovir-resistant infections in immunocompromised patients, and another testing acyclovir in critically ill ICU patients with pneumonia.
The research includes both traditional antiviral medications like acyclovir and innovative approaches such as the HSVTI immunotherapy and the 2LHERP treatment. This variety suggests the medical community is exploring multiple strategies to improve outcomes for people living with herpes simplex infections, particularly those who experience frequent recurrences or have weakened immune systems.
Each trial has specific eligibility requirements, so patients interested in participating should carefully review the criteria and discuss options with their healthcare providers to determine which trial, if any, might be appropriate for their situation.
