Optimization of the ex Vivo Challenge
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|ClinicalTrials.gov Identifier: NCT02134535|
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : January 27, 2016
The overall purpose of this research study is to collect vaginal and cervical biopsies from healthy HIV negative participants. These samples will enable investigators to optimize laboratory methods and explore implementation challenges associated with the ex vivo challenge model. The first objective is to assess which HIV virus is best for use in the model. The second objective is to determine the best endpoint for the assay.
The primary aim of this study is to collect an adequate number of cervical and vaginal biopsies to support the optimization of an ex vivo challenge model. This ex vivo challenge model has been and will continue to be used in topical microbicide clinical trials to predict the efficacy of candidate drugs.
|Condition or disease|
|Optimization of Laboratory Procedures|
The development of surrogates to predict HIV prevention product safety and efficacy is a high priority. An ex vivo challenge model is one such promising surrogate. Colonic tissue exposed to rectally applied microbicides in vivo and then challenged with HIV in the lab showed significant reduction in HIV replication when compared to tissue exposed to placebo gel. Currently, the ex vivo challenge model for ectocervical and vaginal tissue is being developed at the Dezzutti lab at the Magee Womens Research Institute in Pittsburgh, PA. Questions which need to be addressed in order to optimize the model include which HIV virus is most appropriate to use to challenge the tissue, is qPCR a more appropriate endpoint and marker of infection, and can frozen tissue perform as well as fresh tissue in the challenge model.
In this study, we will collect vaginal and cervical biopsies to use in the optimization of laboratory procedures. We will obtain the sample(s) from healthy HIV negative women. Samples will be collected and taken to Magee-Womens Research Institute as laboratory specimens. Written consent will be obtained by an investigator or co-investigator prior to the collection of any samples.
|Study Type :||Observational|
|Actual Enrollment :||73 participants|
|Official Title:||Optimization of the ex Vivo Challenge|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
cervical biopsies vaginal biopsies blood
- cervical biopsy [ Time Frame: Day 1 ]
- vaginal biopsy [ Time Frame: Day 1 ]
- blood draw [ Time Frame: Day 1 ]
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 ClinicalTrials.gov identifier (NCT number): NCT02134535
|United States, Pennsylvania|
|Magee-Womens Hospital of UPMC|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Katherine Bunge, MD||University of Pittsburgh|