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NCT02641444 · ClinicalTrials.gov registry record

Antiretroviral Localization in Gut-Associated Lymphoid Tissue and Lower Female Genital Tract Tissue of HIV+ Subjects

A clinical trial, sponsored by University of North Carolina, Chapel Hill.

Terminated
Registry status
5
Enrollment target

NCT02641444: Clinical Trial study, sponsored by University of North Carolina, Chapel Hill.

NCT02641444 is a clinical trial that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02641444 was terminated before completion, sponsored by University of North Carolina, Chapel Hill.

TERMINATED
Registry status
5 participants
Enrollment target

Study Summary

The purpose of this research study is to find out how the drugs Truvada® (tenofovir/emtricitabine), Isentress® (raltegravir), Reyataz® (atazanavir), Sustiva® (efavirenz), and Selzentry® (maraviroc) get into the intestines and the female genital tract. All of these drugs are very effective at reducing the number of HIV viruses in the blood, however it is unknown how the drugs move around inside tissues where HIV might be hiding. This study will determine specifically where in the tissue the drug and the HIV are located through the use of a new technology that takes creates a picture of the tissue. This information will help scientists determine the best way to make new drugs to target the hidden HIV in tissue.

Primary Outcome

Tissues collected during inpatient stay will be frozen for later analysis (i.e. MSI-derived images of TFV, FTC, RAL, ATZ, EFV, and MVC localization within tissue slices.) to be completed within 6 months of tissue collection.

Interventions

  • PROCEDURE Blood plasma collection
  • PROCEDURE Cervical and Vaginal Biopsy
  • PROCEDURE Colonoscopy with Ileal and Rectal Biopsy

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2016-04-13
Est. Completion 2017-08-29

Why NCT02641444 stopped before completion

NCT02641444 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 5 participants, a relatively small participant target.

The record links to 0 conditions, and to 3 interventions - of which Blood plasma collection is the first listed.

NCT02641444 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02641444 about?

NCT02641444 is a clinical study titled "Antiretroviral Localization in Gut-Associated Lymphoid Tissue and Lower Female Genital Tract Tissue of HIV+ Subjects". The purpose of this research study is to find out how the drugs Truvada® (tenofovir/emtricitabine), Isentress® (raltegravir), Reyataz® (atazanavir), Sustiva® (efavirenz), and Selzentry® (maraviroc) get into the intestines and the female genital tract. All of these drugs are very effective at reducin...

What is the current status of trial NCT02641444?

This trial is currently terminated. The enrollment target is 5 participants. The study started on 2016-04-13. Estimated completion is 2017-08-29.

What interventions are being tested in trial NCT02641444?

The interventions under investigation include: Blood plasma collection (PROCEDURE), Cervical and Vaginal Biopsy (PROCEDURE), Colonoscopy with Ileal and Rectal Biopsy (PROCEDURE).

Who is sponsoring clinical trial NCT02641444?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02641444, the US trial registry maintained by the National Library of Medicine. NCT02641444 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.