ACE STUDY

The ACE study was fully enrolled in May, 2006. All volunteers will have completed their participation by November, 2007, and results from this important study will be available in 2008.

Research Question: Will preventing genital herpes outbreaks among HIV negative people prevent them from getting HIV?

Researchers know that having genital herpes doubles a person's risk of getting HIV if they are exposed. In the U.S., this increased risk may contribute to up to a quarter of new HIV infections.

What we don't know is whether treating herpes, even when a person is not aware of having an outbreak, could reduce the number of new infections worldwide. The ACE Study, therefore, is testing whether a common herpes treatment, when given all the time, will reduce the risk of HIV infection in HIV negative men and women.

In this study, HIV negative participants who have herpes take a common drug to prevent outbreaks, in hopes that will decrease their risk of getting HIV.

Facts

  • In San Francisco, at least 25% of men who have sex with men have genital herpes.
  • Part of the reason that herpes is so widespread may be that an estimated 80% of people who have herpes are unaware of it, because they can't see or feel any symptoms.
  • This study will test whether taking acyclovir, a widely used drug that prevents herpes outbreaks, will break the link between HIV and herpes, and prevent new HIV infections.

Study Design

Participants in the ACE study take acyclovir, a common and widely used drug to suppress herpes outbreaks, or a placebo (sugar pill), daily for 18 months. Any participants who experience herpes outbreaks during the study are treated with acyclovir.

At the end of 18 months, we will compare the number of new HIV infections in each group to find out whether taking acyclovir is effective at preventing new HIV infections.

Acyclovir

Acyclovir reduces the frequency of herpes outbreaks by 80% and reduces viral shedding in genital secretions by 94%. It is very safe, inexpensive and has been used to prevent outbreaks by 40 million people for over 10 years.

ACE Study Participants

Participants are receiving free acyclovir treatment for outbreaks, as well as herpes and HIV testing, risk reduction and adherence counseling. Participants also receive small stipends for study visits.

Other Study Sites

The study recruited men who have sex with men in New York City, San Francisco, Seattle and Lima, Peru. Heterosexual women were recruited in Zimbabwe, Zambia and South Africa.