In short
There is currently 1 ongoing clinical trial for genital herpes simplex (also known as HSV-2 genital infection, recurrent genital herpes). This trial is evaluating a new weekly oral medication called IM-250 as a suppressive therapy to help control recurring herpes outbreaks. The study is being conducted in Bulgaria and involves comparing different doses of the investigational drug against placebo.
Clinical trial locations
Study of IM-250 capsules compared to placebo in patients with recurrent genital herpes
This clinical trial is testing a new medication called IM-250, which is taken as oral capsules once per week. The study aims to determine if this treatment can help control recurring herpes outbreaks when used as a long-term preventive therapy. The medication is being evaluated in a double-blind study, meaning neither the participants nor the medical staff know who receives the actual treatment or placebo during the trial.
Who can participate:
- Adults between 18 and 65 years old
- Both men and women who agree to follow contraceptive requirements
- People with a confirmed history of genital herpes (HSV-2) for at least 12 months, verified by laboratory tests
- Those who experience 3 to 9 outbreaks per year, either while on current suppression medication or without treatment
- Participants must be willing to stop any existing antiviral treatments at least 14 days before starting the study medication
- Ability to understand and provide written informed consent
Who cannot participate:
- People younger than 18 or older than 65 years
- Pregnant or breastfeeding women
- Those with a history of allergic reactions to similar medications or previous adverse reactions to antiviral drugs
- People with weakened immune systems due to medications or medical conditions
- Those with severe kidney or liver disease
- People with uncontrolled medical conditions such as diabetes or high blood pressure
- Those with significant heart problems or abnormal heart rhythm
- People with a history of drug or alcohol abuse within the past year
- Those with mental health conditions that could affect their ability to provide informed consent
- People currently taking medications that could interact with the study drug
- Those unable to practice effective contraception during the study period
What the study involves:
Participants receive weekly oral doses of either IM-250 (50mg capsules) or placebo for 56 days. During this time, they must collect daily genital swabs for laboratory testing and keep track of any genital lesions that appear. The medical team monitors how often the virus becomes active (viral shedding) and tracks the occurrence of herpes outbreaks.
The study evaluates the frequency of genital lesions during both the first 28 days and the complete 56-day treatment period. Blood samples are taken to measure the levels of study medication in the body. Researchers compare results between participants who received different doses of IM-250 and those who received placebo to understand how well the medication works and how safe it is.
The investigational drug:
IM-250 is a new medication currently in Phase 1b/2a testing. It is designed to be taken weekly rather than daily, which could offer convenience compared to existing therapies. The medication is being developed specifically for immune-mediated control of herpes virus outbreaks, though researchers are still evaluating its exact effectiveness and safety profile as part of these clinical trials.
Summary
Currently, there is one active clinical trial for genital herpes simplex, conducted in Bulgaria. The study focuses on evaluating IM-250, a weekly oral medication designed as suppressive therapy for people who experience recurring herpes outbreaks. The trial represents a potential advancement in treatment convenience, as the weekly dosing schedule differs from traditional daily therapies. Participants in this study undergo regular monitoring over an 8-week period to assess both the safety and effectiveness of the investigational drug compared to placebo.
