Understanding HIV Susceptibility in the Female Genital Tract

HIV Infections Clinical Trial

Official title:

Understanding HIV Susceptibility in the Female Genital Tract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03064425
• Other study ID #: 14-007
• Status: Completed
• Start date: January 2015
• Est. completion date: January 2017

Study information

• Verified date: February 2019
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease Susceptibility
• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Type of infected CD4 cells	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.	Assay to be conducted within 24 hours of sample collection