Understanding HIV Susceptibility in the Female Genital Tract
|ClinicalTrials.gov Identifier: NCT03064425|
Recruitment Status : Completed
First Posted : February 27, 2017
Last Update Posted : February 22, 2019
|Condition or disease||Intervention/treatment|
|HIV Infections||Biological: Vaginal and blood sample collection|
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.
|Study Type :||Observational|
|Actual Enrollment :||98 participants|
|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|
- 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.
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03064425
|Principal Investigator:||Mark Yudin, MD||St. Michael's Hospital, Toronto|