View Clinical Trial (Medical Research Study)
Vaginal Innate Immunity in Normal and HIV-Infected Women
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02118 |
| Conditions: |
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HIV - Pregnancy |
| Purpose: |
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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.
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| Study Summary: |
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| 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)
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| NCT ID: |
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NCT01318304 |
| Primary Contact: |
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Principal Investigator
Jennifer Ballard Dwan, M.D.
Boston University
Jennifer Ballard Dwan, M.D.
Phone: 617-414-3745
Email: jennifer.dwan@bmc.org
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| Backup Contact: |
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Email: deborah.anderson@bmc.org
Deborah Anderson, Ph.D.
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| Location Contact: |
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Boston, Massachusetts 02118
United States
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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