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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: Completed NA study, sponsored by University of Washington.
NCT01327482 is a NA study that has completed, run by University of Washington. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Mean trough concentration from all three days. Tissue concentrations are measured from cervical biopsy homogenate using a mass-spectroscopy-based method.
Interventions
- DRUG Raltegravir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-10 |
| Phase | NA |
What the finished NCT01327482 record still lists
NCT01327482 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Raltegravir is the first listed.
NCT01327482 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01327482's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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