Working… Menu

Optimization of the ex Vivo Challenge

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02134535
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : January 27, 2016
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Katherine Bunge, University of Pittsburgh

Tracking Information
First Submitted Date May 7, 2014
First Posted Date May 9, 2014
Last Update Posted Date January 27, 2016
Study Start Date May 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 7, 2014)
  • cervical biopsy [ Time Frame: Day 1 ]
  • vaginal biopsy [ Time Frame: Day 1 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 7, 2014)
blood draw [ Time Frame: Day 1 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Optimization of the ex Vivo Challenge
Official Title Optimization of the ex Vivo Challenge
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.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy, non-pregnant, HIV negative women
Condition Optimization of Laboratory Procedures
Intervention Not Provided
Study Groups/Cohorts laboratory specimens
cervical biopsies vaginal biopsies blood
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 26, 2016)
Original Estimated Enrollment
 (submitted: May 7, 2014)
Actual Study Completion Date March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Age 18-45
  2. Free from abnormal vaginal discharge or other current vaginal symptoms
  3. HIV uninfected. Note: if a woman recently participated in a recent research study and has an HIV test result available from that study, this will suffice provided the date of the test is within 6 months of the enrollment visit for this trial. Otherwise, the potential participant should under go testing at the first study visit.
  4. Willing and able to give informed consent to take place in the study
  5. Willing to undergo a pelvic examination and genital biopsies
  6. Willing to provide contact information
  7. Agree to be sexually abstinent for two weeks beginning one week prior to the enrollment visit

Exclusion Criteria:

  1. Menopausal
  2. Pregnant or within 90 days of last pregnancy
  3. Hysterectomy
  4. Use of a diaphragm, NuvaRing or spermicide for contraception
  5. Reports a course of antibiotic therapy in the 14 days prior to enrollment
  6. Known history of platelet disorder or coagulapathy.
  7. Participation in another microbicide or contraceptive study or a study involving cervical and/or vaginal biopsies within one month of enrollment
  8. Use of any spermicide or spermicide-lubricated condom within one week of enrollment.
  9. Use of any internal vaginal device or product with the exception of tampons within one week of enrollment
  10. Any other condition that in the opinion of the site investigator would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Sexes Eligible for Study: Female
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT02134535
Other Study ID Numbers PRO13120447
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Katherine Bunge, University of Pittsburgh
Study Sponsor University of Pittsburgh
Collaborators Bill and Melinda Gates Foundation
Principal Investigator: Katherine Bunge, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date January 2016