Vaginal Innate Immunity in Normal and HIV-Infected Women
NCT ID: NCT01318304
Last Updated: 2016-05-09
Study Results
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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COMPLETED
83 participants
OBSERVATIONAL
2010-10-31
2013-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pregnant, HIV- negative
This cohort has completed accrual as of 12/28/11.
Vaginal lavage specimen
Collection of 3cc of saline used in the vagina to collect innate immunity markers
Pregnant, HIV-positive
Vaginal lavage specimen
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
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
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
Eligibility Criteria
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Inclusion Criteria
* Age 18 - 40 years
* Able to provide informed consent
Exclusion Criteria
* 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)
18 Years
40 Years
FEMALE
Yes
Sponsors
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Boston Medical Center
OTHER
Responsible Party
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Joseph Politch
Faculty, OBGYN
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
Countries
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Other Identifiers
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H-29331
Identifier Type: -
Identifier Source: org_study_id
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