HSV and HIV Tissue Reservoirs Study

Principal Investigator:
Christine Johnston, MD, MPH

Study Description:
The purpose of this study is to understand whether immune responses to herpes simplex virus type 2 bring HIV infected cells to the genital tract in men and women with HIV infection. The study will last for 5 months and involve 8 clinic visits. Participants will be asked to collect daily genital samples from home for 30-days and be provided valacyclovir, a standard herpes medication, which they will take for 4 months. Clinic visits will involve blood draws and genital biopsies at the site of genital HSV lesions. Women will undergo cervical sampling and cervical biopsies. Men will undergo rectal biopsies. Participants will be followed for one year and will be asked to return to the clinic if they have a genital herpes outbreak for 2 extra visits for blood draws and additional genital and cervical/rectal biopsies.

Eligibility Criteria:

  • 18 years of age or older
  • Infected with HIV
  • Currently taking at least 2 active antiretroviral medications with an HIV plasma RNA level (viral load) <40 copies/ml
  • HSV‐2 seropositive or seronegative
  • Willing to stop taking daily anti-HSV suppressive therapy

Exclusions (conditions which would prevent a volunteer from participating in this study):

  • CD4 count < 100 cells/mm3
  • Women only: Pregnant or planning to become pregnant during the study
  • Women only: Presence of an IUD (intrauterine device)

Location:
UW Virology Research Clinic
908 Jefferson St, 11th Floor
Seattle, WA 98104

Compensation:
Participants will receive up to $675 for completing the study. Participants that have HSV and return for an outbreak visit, will receive an additional $500 for the 2 extra visits.



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