Vaginal Innate Immunity in Normal and HIV-Infected Women

Boston Medical Center (BMC)

Status

Completed

Conditions

HIV

Pregnancy

Treatments

Other: Vaginal lavage specimen

Study type

Observational

Funder types

Other

Identifiers

NCT01318304

H-29331

Details and patient eligibility

About

The innate immunity of the vaginal tract provides first-line defense from abnormal microorganisms or overgrowth of common organisms, such as Candida species or Gardnerella vaginalis. It is unclear from the current available literature whether the rate of vaginal infection increases or decreases in frequency during pregnancy when compared to the non-pregnant state, but this may be predicted by shifts in vaginal innate immunity. Vaginal infections are important players in HIV disease, potentially increasing the risk of viral transmission. In addition, these infections may activate inflammatory markers in the reproductive tract and increase the risk of premature delivery or other negative pregnancy outcomes. The vaginal innate immune system has not been well characterized in pregnant women, or in women with HIV infection. The study of how this system changes in pregnancy and HIV infection will provide essential knowledge for further study of vaginal mucosal protection.

The investigators study is an observational study designed to compare levels of vaginal innate immunity markers in women based on a) pregnancy status and b) HIV infection status. Comparisons will be made between pregnant and non- pregnant women and between HIV positive and HIV negative women. The investigators hypothesize that there will be significant differences in levels of innate immunity between the groups.

Enrollment

83 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Female
Age 18 - 40 years
Able to provide informed consent

Exclusion criteria

Women with the following conditions will be excluded:
Currently active Syphilis or Herpes simplex infection
Other (non-HIV) comorbid conditions causing acute or chronic inflammatory states or immunosuppression (i.e., transplant recipients, active systemic lupus)
Current use of hormonal birth control or with IUD in place
History of Hysterectomy or bilateral oophorectomy

Women with the following conditions will require rescheduling of the study visit:

Use of hot tub or pool, vaginal creams, douches, vaginal medications, or vaginal intercourse within 48 hours
Current vaginal bleeding
Recent treatment for vaginal infection will require 4 - 6 week delay in enrollment

Pregnant women with the following conditions at the time of examination will be excluded: