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NCT01327482 · ClinicalTrials.gov registry record · NA
Levels of Raltegravir in the Female Genital Tissue
A NA study, sponsored by University of Washington.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT01327482 is a NA study that has completed, run by University of Washington. The registered enrollment target is 10 participants.
The verdict
NCT01327482, a NA study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study is an investigation of the pharmacokinetics of raltegravir in the tissue of the female genital tract to determine if twice-daily dosing of 400mg achieves adequate drug levels to prevent viral integration of HIV-1. The study will also assess whether drug levels change in the tissue across the different phases of the menstrual cycle. * Hypothesis #1: Twice daily dosing with raltegravir 400mg will result in intracellular concentrations that should be sufficient to suppress HIV-1 replication throughout the menstrual cycle. * Hypothesis #2: Intracellular genital raltegravir peaks will be lower and troughs higher compared to extracellular concentrations in the plasma and PMBCs (peripheral blood mononuclear cells). * Hypothesis #3: Intracellular raltegravir concentrations will be slightly lower during the luteal phase of the menstrual cycle due to cellular pumps such as p-glycoprotein, which are present in higher numbers during periods of high progesterone.
Interventions
- DRUG Raltegravir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01327482
The ClinicalTrials.gov registry entry for NCT01327482 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Raltegravir is the first listed.
NCT01327482 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01327482 about?
NCT01327482 is a clinical study titled "Levels of Raltegravir in the Female Genital Tissue". This study is an investigation of the pharmacokinetics of raltegravir in the tissue of the female genital tract to determine if twice-daily dosing of 400mg achieves adequate drug levels to prevent viral integration of HIV-1. The study will also assess whether drug levels change in the tissue across ...
What is the current status of trial NCT01327482?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2011-10.
What interventions are being tested in trial NCT01327482?
The interventions under investigation include: Raltegravir (DRUG).
Who is sponsoring clinical trial NCT01327482?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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