Understanding HIV Susceptibility in the Female Genital Tract

NCT03064425 | Completed

• 1 other identifier: 14-007
• Study Type: observational
• Target: 98
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• CD4 cell infection

  The absolute number of CD4+ cells per cytobrush that are infected by HIV

  Assay to be conducted within 24 hours of sample collection

Secondary Outcomes (1)

• Type of infected CD4 cells

  Assay to be conducted within 24 hours of sample collection

Interventions

Vaginal and blood sample collection BIOLOGICAL

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.

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: Non-pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is recruiting healthy non-pregnant women from the St. Michael's Gynecology clinic.

You may qualify if:

• women over the age of 18 years

You may not qualify if:

• pregnant
• actively menstruating
• known HIV infection
• genital ulceration or discharge on history or physical examination

Sponsors & Collaborators

• Unity Health Toronto: lead

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Mark Yudin, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: February 27, 2017
• Study Start: January 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: February 22, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share