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Optimization of the ex Vivo Challenge

NCT02134535 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 73

Last updated 2016-01-27

No results posted yet for this study

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.

Conditions

  • Optimization of Laboratory Procedures

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Katherine Bunge, MD · University of Pittsburgh

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02134535 on ClinicalTrials.gov