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NCT01318304 · ClinicalTrials.gov registry record

Vaginal Innate Immunity in Normal and HIV-Infected Women

A clinical trial, sponsored by Boston Medical Center.

Completed
Registry status
83
Enrollment target

NCT01318304: Completed study, sponsored by Boston Medical Center.

NCT01318304 is a clinical trial that has completed, run by Boston Medical Center. The registered enrollment target is 83 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01318304 has completed, sponsored by Boston Medical Center.

COMPLETED
Registry status
83 participants
Enrollment target

Study 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.

Primary Outcome

Investigators will quantify the major vaginal innate immunity markers, including type 1 (alpha and beta) interferons, defensins, cathelicidins, lysozyme and lactoferrin, and secretory leukocyte protease inhibitor (SLPI). These antimicrobial host defense peptides are produced by genital tract mucosal epithelial cells and associated immune cells, and have a wide range of antiviral, antibacterial, antifungal and antiparasitic activities and modes of action. We hypothesize that changes in innate imm

Interventions

  • OTHER Vaginal lavage specimen

Trial Details

FieldValue
Enrollment Target 83 participants
Start Date 2010-10
Est. Completion 2013-04
Boston Medical Center

253 total trials

What the finished NCT01318304 record still lists

NCT01318304 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 83 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Vaginal lavage specimen is the first listed.

NCT01318304 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01318304 about?

NCT01318304 is a clinical study titled "Vaginal Innate Immunity in Normal and HIV-Infected Women". 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 f...

What is the current status of trial NCT01318304?

This trial is currently completed. The enrollment target is 83 participants. The study started on 2010-10. Estimated completion is 2013-04.

What interventions are being tested in trial NCT01318304?

The interventions under investigation include: Vaginal lavage specimen (OTHER).

Who is sponsoring clinical trial NCT01318304?

This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01318304, the US trial registry maintained by the National Library of Medicine. NCT01318304 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.