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NCT02375425 · ClinicalTrials.gov registry record
Optimization of the ex Vivo Challenge: Reproductive Infections and Contraception
A clinical trial, sponsored by University of Pittsburgh.
- Completed
- Registry status
- 294
- Enrollment target
NCT02375425 is a clinical trial that has completed, run by University of Pittsburgh. The registered enrollment target is 294 participants.
The verdict
NCT02375425 has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- 294 participants
- Enrollment target
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.
Interventions
- OTHER no intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 294 participants |
| Start Date | 2015-06 |
| Est. Completion | 2016-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02375425
The ClinicalTrials.gov registry entry for NCT02375425 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 294 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which no intervention is the first listed.
NCT02375425 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02375425 about?
NCT02375425 is a clinical study titled "Optimization of the ex Vivo Challenge: Reproductive Infections and Contraception". 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 ...
What is the current status of trial NCT02375425?
This trial is currently completed. The enrollment target is 294 participants. The study started on 2015-06. Estimated completion is 2016-06.
What interventions are being tested in trial NCT02375425?
The interventions under investigation include: no intervention (OTHER).
Who is sponsoring clinical trial NCT02375425?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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