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Therapeutic Areas: Immunology | Dermatology | Obstetrics/Gynecology (Women’s Health) | Infections and Infectious Diseases
Disease Category: Herpes Simplex Infections
Location: United States, NY

Clinical Trial Details

Overview

Research Study Summary

Impact of Herpes Simplex Virus-2 on Female Genital Tract Mucosal Immunity and HIV Infection

Purpose

We are looking for women who are 18 or older who have HIV and genital herpes infection OR HIV and no history of genital herpes. In this study, there will be 13 visits over 3 months. Women will be asked to collect swabs from their vagina, which will be returned to the clinic once each week. Women will also be asked to come in for additional visits if they have herpes outbreaks. The purpose of this research study is to see if genital herpes changes the cells in the vagina that protect women against infections.

There will be pelvic exams and blood draws at 3 visits and herpes outbreak visits. At the first visit and visits during herpes outbreaks, the clinician will take a small piece of skin from the vagina, called a biopsy. At each visit where women return swabs to the clinic, the clinician will take an additional vaginal swab (without doing a speculum exam).

Participants will be reimbursed for time and travel at every visit. They will receive a Metrocard (valued at $4.50) at each visit and $250 total.

Patient Inclusion Criteria:

  • 18 years of age or older
  • HIV infection
  • Have a cervix

Patient Exclusion Criteria:

  • Pregnancy
  • History of high grade cervical dysplasia (within the past year) or a history of cervical cancer
  • Current use or desire to use suppressive anti-herpes treatment (like valtrex, famvir, or acyclovir)

To Learn more
Gender

Female

Age

18 and up

Overall Status

Recruiting

Duration

3 Months

Facility Type

N/A

Compensation

Up to $250

Contact

Lily Espinoza, Study Coordinator
The Harold & Muriel Block Institute for Clinical and Translational Research at Einstein & Montefiore
Albert Einstein College of Medicine 1300 Morris Park Avenue
Bronx, NY 10461
Phone: 718-430-3253
Fax: 718-430-8879

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If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 175371

Date Last Changed: July 22, 2013


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