The trial aims to evaluate the safety and efficacy of an experimental drug for the treatment of recurrent genital herpes caused by herpes simplex virus type 2 (HSV-2)
Currently the approved drugs to treat or to prevent recurrent genital herpes (RGH) do not always work 100%. Also, in order to prevent the recurrences, patients need to take multiple pills every day. ABI-1179 showed strong activity against herpes viruses that cause genital herpes in the laboratory and it is now being tested to see if it would work to prevent RGH in people living with the condition.
This clinical trial also aims to identify the most effective dose(s) of ABI-1179 in reducing recurrent genital herpes by measuring how much of the virus is present in swabs that are collected from participants.
Anticipated enrolment close date: December 2025
Who can take part
You may be able to take part if you:
- are aged 18 to 60 years inclusive
- have a history of recurrent genital herpes between 4 and 9 episodes in the last 12 months
- other than the HSV infection, are in good health
- are willing to discontinue current HSV treatment 7 days prior to starting the study and 7 days after receiving the last dose of the treatment
- are not planning to become pregnant for the next 3 months
What's involved
- This is a randomised, blinded research project where participants will by chance receive either the trial medication or a placebo. A placebo looks exactly like the trial medication but does not contain the active ingredients that are contained in the test medication.
- The treatment will consist of 5 weekly oral doses of the study medication or the placebo between Day 1 and Day 29. All participants will be followed up for 4 weeks after the treatment period ends.
- Participants will undergo several tests and procedures before, during, and upon completion of their participation in the trial. The procedures will include collection of blood and urine samples for laboratory testing.
- Participants will also be asked to collect swab samples from their anal and genital regions. These swabs will be tested to measure the level of HSV2 present.
- The trial staff will explain the tests and procedures in details during the first trial visit.
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.