Clinical trial NCT01318304: Vaginal Innate Immunity in Normal and HIV-Infected Women
Official title: Vaginal Innate Immunity in Normal and HIV-Infected Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Pregnancy
Keywords: innate immunity
HIV
pregnancy
vaginal immunity
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2011-03-18
Enrollment: 83
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy women, 18 to 40 years old, with spontaneous menstrual cycles or with normal ongoing pregnancy with gestational age between weeks 13 - 30 and able to provide informed consent

Brief summary: 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.


Eligibility criteria: 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:

* Active labor or other conditions of duress
* Signs or symptoms of preterm labor
* Vaginal bleeding
* Placenta previa
* History of prior preterm birth
* Ruptured amniotic membranes
* Multifetal gestation
* Stillbirth or intrauterine fetal demise (IUFD)

Primary outcomes:
measure: To compare the vaginal concentrations innate immunity markers (alpha / beta interferons, defensin, cathelicidin, lysozyme, lactoferrin, and SLPI) in pregnant and non-pregnant women who are HIV-negative.
timeFrame: up to 2 clinic visits in 10 weeks
Secondary outcomes:
measure: To compare the vaginal concentrations of innate immunity markers (alpha and beta) interferon, defensin, cathelicidin, lysozyme, lactoferrin, and SLPI)) in HIV-positive pregnant and non-pregnant women
timeFrame: up to 2 clinic visits in 10 weeks
measure: To compare the vaginal concentrations innate immunity markers (alpha / beta interferons, defensin, cathelicidin, lysozyme, lactoferrin, and SLPI) in pregnant women who are HIV-negative to pregnant women who are HIV-positive.
timeFrame: up to 2 clinic visits in 10 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Jennifer Ballard Dwan, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Deborah Anderson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: