HERA Study

Study Name

Herpesviruses Reactivation in HIV-Infected Women Initiating ART (HERA)

Study Number


Goal of Study

The NIH is conducting a research study about the effects of HIV treatment in women who may have herpes virus infections. Herpes virus can cause sores on the vagina, around the mouth, or on the skin. It can also cause flu-like symptoms such as fever and muscle aches. Another type of herpes virus can cause shingles or chickenpox, and another type can cause Kaposi sarcoma, a type of cancer that can affect the skin or other body organs like the mouth, gut, or lungs. Herpes viruses do not always cause symptoms, so people with herpes virus infection may not know that they have it. 

Many people with HIV also have infections with herpes virus. When these people start taking HIV medicines, their herpes virus symptoms can suddenly start or become worse. We are inviting you to participate in this study so that we can look at how often this happens and why. In this study, we will measure herpes infection in women who are starting HIV treatment. The medicine used to treat HIV is called "antiretroviral therapy," or "ART" for short. The ART medications we are using on this study are approved by the U.S. Food and Drug Administration for HIV treatment. We will study changes that happen in the body when a person starts ART and how those changes may make herpes virus symptoms worse. 

Study Regimen

The study will last about one year.  We will enroll about 200 women on this study. This study will take place at the NIH and at a health clinic in Uganda.  Your study visits will be at the NIH Clinical Center in Bethesda, Maryland.  Study procedures include physical exams, blood draws, pregnancy testing, fluid collection, and plasma collection.  ART will be provided while on study only, and volunteers will be compensated.

Eligibility Criteria

  • You are a woman age 18 years or older and living with HIV
  • You have a doctor responsible for your care
  • You have never taken HIV medications, or you took HIV medications for less than three months, at least six months ago
  • You agree to start taking HIV medications for the study; these medications will need to be provided by your doctor after your study participation is over
  • You have herpes virus
  • You are not pregnant, breastfeeding, or trying to become pregnant
  • You are available to come to the NIH in Bethesda, Maryland for study visits
Content last reviewed on June 13, 2018