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NCT01330199 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetics of Tenofovir, Emtricitabine, Maraviroc, and Raltegravir in Cervical, Vaginal, and Rectal Tissues and Secretions

A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
Phase 1
Development phase
49
Enrollment target

NCT01330199 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 49 participants.

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The verdict

NCT01330199, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
Phase 1
Development phase
49 participants
Enrollment target

Study Summary

The purpose of this study is to develop a predictive antiretroviral pharmacokinetic model of mucosal fluid and tissue distribution in genital tract fluid, rectal fluid and 3 mucosal tissues. This will be accomplished by determining the pharmacokinetic disposition and dose proportionality of four antiretrovirals (tenofovir, emtricitabine, maraviroc, and raltegravir) in human rectal and cervicovaginal fluid and rectal, cervical, and vaginal tissue.

Interventions

  • OTHER Pharmacokinetic Sampling

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2012-02
Est. Completion 2013-08
Phase Phase 1

What the Registry Record Tells You About NCT01330199

The ClinicalTrials.gov registry entry for NCT01330199 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Pharmacokinetic Sampling is the first listed.

NCT01330199 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01330199 about?

NCT01330199 is a clinical study titled "Pharmacokinetics of Tenofovir, Emtricitabine, Maraviroc, and Raltegravir in Cervical, Vaginal, and Rectal Tissues and Secretions". The purpose of this study is to develop a predictive antiretroviral pharmacokinetic model of mucosal fluid and tissue distribution in genital tract fluid, rectal fluid and 3 mucosal tissues. This will be accomplished by determining the pharmacokinetic disposition and dose proportionality of four ant...

What is the current status of trial NCT01330199?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2012-02. Estimated completion is 2013-08.

What interventions are being tested in trial NCT01330199?

The interventions under investigation include: Pharmacokinetic Sampling (OTHER).

Who is sponsoring clinical trial NCT01330199?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.