This research study is to evaluate an experimental medication for people with Herpes Simplex Virus Type 2 (HSV-2)
The purpose of this study is to determine the safety and effects of experimental medication (ABI-5366) for the treatment of individuals who have recurrent genital herpes caused by HSV-2. This research study will also try to find which dose(s) of ABI-5366 may reduce recurrent genital herpes by measuring how much of the virus is present in swabs collected from participants.
Who can take part
This trial might be appropriate for you if you:
- are between 18 and 60 years of age
- have a history of recurrent genital herpes - between 4 to 9 episodes (inclusive) in the last 12 months
- outside of the HSV infection, are otherwise in good health
- willing to discontinue current HSV treatment 7 days prior commencing the study and 7 days after the last study dose (36-day study)
You cannot participate if you are planning to become pregnant for the next three months.
What's involved for you
This is a randomised, blinded research project where participants will receive either the study medication or a placebo.
Treatment will consist of 5 weekly oral doses of the study medication or the placebo between Day 1 and Day 29. A placebo looks exactly like the study medication but does not contain the active ingredients that are contained in the test medication. All participants will be followed up after the treatment period.
You will undergo several tests and procedures before, during, and upon completion of your participation in the study. The study staff will explain the tests and procedures to you. The tests and procedures will involve collection of blood and urine. You will also be asked to collect your own swab samples from your anal and genital regions. These swabs will be tested to measure the level of HSV present.
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.