MedTrace Logo

Optimization of the ex Vivo Challenge: Reproductive Infections and Contraception

NCT02375425 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 294

Last updated 2018-12-24

No results posted yet for this study

Summary

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 under development at the Dezzutti lab at the Magee Womens Research Institute in Pittsburgh, PA. Currently the Reproductive Infectious Disease Research Group is conducting a study designed to answer important questions about the ex vivo challenge model:which HIV virus is the best to use in the laboratory and what is the best indicator of HIV infection. The proposed study delineated here will investigate the effect of BV, HSV and contraceptive use on the model . There will be two arms to the study; the first will investigate the impact of HSV and BV status and the second, contraceptive use. Vaginal and cervical biopsies will be collected from participants for the ex vivo challenge model.

Conditions

Interventions

OTHER

no intervention

no intervention-specimen collection study only

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
2015-06-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02375425 on ClinicalTrials.gov