HIVNCT01318304
Vaginal Innate Immunity in Normal and HIV-Infected Women
An observational study of HIV and Pregnancy, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- What is being tested?
- Vaginal lavage specimen
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- Female
- Age 18 - 40 years
- Able to provide informed consent
Who cannot join
- 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:
Show all 18Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Medical Center
Boston, Massachusetts, 02118
About this study
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.
- Being tested
- Vaginal lavage specimen
- Keywords
- innate immunity, HIV, pregnancy, vaginal immunity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal lavage specimenOther
Collection of 3cc of saline used in the vagina to collect innate immunity markers
| Study group | Role | What they receive |
|---|---|---|
| Pregnant, HIV- negative | This cohort has completed accrual as of 12/28/11. Receives: Other: Vaginal lavage specimen | |
| Pregnant, HIV-positive | Not described Receives: Other: Vaginal lavage specimen | |
| Non-pregnant, HIV-negative | This cohort has completed accrual as of 12/28/11. Receives: Other: Vaginal lavage specimen | |
| Non-pregnant, HIV-positive | This cohort has completed accrual as of 12/28/11. Receives: Other: Vaginal lavage specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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 immunity markers take place during pregnancy, thereby changing native vaginal immunity.
Measured: up to 2 clinic visits in 10 weeks
Secondary outcomes (2)
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
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). Women who have HIV may express different innate immunity marker profiles in vaginal secretions when pregnant as compared to non-pregnant HIV positive women. Timing of specimen collection: In pregnancy: Weeks 13 - 30. Non-pregnant: 3 weeks between menstrual bleeding cycles
Measured: up to 2 clinic visits in 10 weeks
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.
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). Women with HIV may express different innate immunity marker profiles in vaginal secretions when pregnant as compared to pregnant, HIV-negative women. This may provide some explanation for differences in vaginal infection rates between the groups. Timing of specimen collection: In pregnancy: Weeks 13 - 30.
Measured: up to 2 clinic visits in 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startOct 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Politch, Boston Medical Center
- Investigators
- Jennifer Ballard Dwan, M.D., Principal investigator, Boston UniversityDeborah Anderson, Ph.D., Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318304
- Sponsor's protocol ID
- H-29331
- Status last verified
- May 2016
- First submitted
- 29 Oct 2010
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Innate Immunity in Normal and HIV-Infected Women
- ClinicalTrials.gov ID
- NCT01318304
- Acronym / sponsor ID
- H-29331
- Keywords
- innate immunity, HIV, pregnancy, vaginal immunity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 18 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pregnant, HIV- negative | – | Other: Vaginal lavage specimenThis cohort has completed accrual as of 12/28/11. |
| Pregnant, HIV-positive | – | Other: Vaginal lavage specimen |
| Non-pregnant, HIV-negative | – | Other: Vaginal lavage specimenThis cohort has completed accrual as of 12/28/11. |
| Non-pregnant, HIV-positive | – | Other: Vaginal lavage specimenThis cohort has completed accrual as of 12/28/11. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (3 listed)
- Female
- Age 18 - 40 years
- Able to provide informed consent
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal lavage specimenCollection of 3cc of saline used in the vagina to collect innate immunity markers | Other | Non-pregnant, HIV-negative, Non-pregnant, HIV-positive, Pregnant, HIV- negative, Pregnant, HIV-positive |
Primary outcome
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.
Time frame: up to 2 clinic visits in 10 weeks
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 immunity markers take place during pregnancy, thereby changing native vaginal immunity.
2 secondary outcomes
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
Time frame: up to 2 clinic visits in 10 weeks
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.
Time frame: up to 2 clinic visits in 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Ballard Dwan, M.D. principal investigator
Boston University
Deborah Anderson, Ph.D. principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Pregnancy, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: up to 2 clinic visits in 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2016.