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Understanding HIV Susceptibility in the Female Genital Tract

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03064425
Recruitment Status : Completed
First Posted : February 27, 2017
Last Update Posted : February 22, 2019
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Brief Summary:
There is great variability in susceptibility from one person to another, and less than one in a hundred sexual exposures to HIV results in infection. In addition, some recent trial of methods to prevent HIV - including vaccines and microbicides - have actually increased HIV acquisition among trial participants for reasons that we do not fully understand. While we know that immune differences in the genital lining are an important determinant of whether a person is infected after a sexual HIV exposure, we don't know enough about these differences to be able to accurately assess a person's individual HIV risk. Therefore, the development of safe and non-invasive laboratory tests to estimate a person's susceptibility in the genital tract would be useful in clinical studies of new HIV prevention tools.

Condition or disease Intervention/treatment
HIV Infections Biological: Vaginal and blood sample collection

Detailed Description:

Heterosexual intercourse is the most common mode of transmission of HIV, but the risk of HIV acquisition after exposure is so low that studies to assess HIV risk must have a huge sample size. The goal of this study is to assess the suitability of a prototype pseudovirus assay to identify early HIV target cells in the female genital tract, using cervical cytobrush samples collected from healthy women, and to optimize assay sensitivity.

This novel HIV entry assay may overcome the need for a large sample size by directly measuring how susceptible a person is by using a sample similar to a PAP test. The assay is performed on immune cells obtained from a cervical cytobrush and enables assessment of HIV cell entry within 24 hours. If the assay works, this technique may have the potential to assess the impact of clinical parameters such as stage of menstrual cycle, or sexually transmitted infections and their treatment on HIV susceptibility in the female genital tract. Therefore, the assay may serve as an important monitoring tool in clinical trials of HIV prevention, serving as an invaluable intermediate endpoint to assess HIV acquisition risk, rather than relying on actual participant HIV seroconversion/infection.

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Study Type : Observational
Actual Enrollment : 98 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Understanding HIV Susceptibility in the Female Genital Tract
Actual Study Start Date : January 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Intervention Details:
  • Biological: Vaginal and blood sample collection
    The researchers will obtain approximately 20 mL of blood from participants. Participants will also undergo a pelvic exam where a sample of cells will be collected from the cervix using two small cytobrushes. In addition, a cervicovaginal lavage will be collected using saline.

Primary Outcome Measures :
  1. CD4 cell infection [ Time Frame: Assay to be conducted within 24 hours of sample collection ]
    The absolute number of CD4+ cells per cytobrush that are infected by HIV

Secondary Outcome Measures :
  1. Type of infected CD4 cells [ Time Frame: Assay to be conducted within 24 hours of sample collection ]
    Nature of the CD4+ cells that are infected, ie: identification of immune characteristics that are associated with preferential HIV cell entry. Parameters to be assessed include immune activation markers and the expression of HIV coreceptors and integrins.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Non-pregnant women
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study is recruiting healthy non-pregnant women from the St. Michael's Gynecology clinic.

Inclusion Criteria:

  • women over the age of 18 years

Exclusion Criteria:

  1. pregnant
  2. actively menstruating
  3. known HIV infection
  4. genital ulceration or discharge on history or physical examination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03064425

Sponsors and Collaborators
St. Michael's Hospital, Toronto
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Principal Investigator: Mark Yudin, MD St. Michael's Hospital, Toronto

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Responsible Party: St. Michael's Hospital, Toronto Identifier: NCT03064425     History of Changes
Other Study ID Numbers: 14-007
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease Susceptibility
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Disease Attributes
Pathologic Processes