Vaginal Innate Immunity in Normal and HIV-Infected Women

NCT ID: NCT01318304

Last Updated: 2016-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant, HIV- negative

This cohort has completed accrual as of 12/28/11.

Vaginal lavage specimen

Intervention Type OTHER

Collection of 3cc of saline used in the vagina to collect innate immunity markers

Pregnant, HIV-positive

Vaginal lavage specimen

Intervention Type OTHER

Collection of 3cc of saline used in the vagina to collect innate immunity markers

Non-pregnant, HIV-negative

This cohort has completed accrual as of 12/28/11.

Vaginal lavage specimen

Intervention Type OTHER

Collection of 3cc of saline used in the vagina to collect innate immunity markers

Non-pregnant, HIV-positive

This cohort has completed accrual as of 12/28/11.

Vaginal lavage specimen

Intervention Type OTHER

Collection of 3cc of saline used in the vagina to collect innate immunity markers

Interventions

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Vaginal lavage specimen

Collection of 3cc of saline used in the vagina to collect innate immunity markers

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Joseph Politch

Faculty, OBGYN

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Ballard Dwan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Boston University

Deborah Anderson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

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Boston University Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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H-29331

Identifier Type: -

Identifier Source: org_study_id

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