Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-01-03 @ 6:37 PM
Study NCT ID:
NCT02134535
Status:
COMPLETED
Last Update Posted:
2016-01-27
First Post:
2014-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimization of the ex Vivo Challenge
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
Optimization of the ex Vivo Challenge
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: