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NCT01326221 · ClinicalTrials.gov registry record
Single Dose Truvada in HIV-negative Men and Women
A clinical trial, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- 12
- Enrollment target
NCT01326221: Completed study, sponsored by University of North Carolina, Chapel Hill.
NCT01326221 is a clinical trial that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01326221 has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- 12 participants
- Enrollment target
Study Summary
This open-label, non-blinded, pharmacokinetic (PK) study will assess both tenofovir and emtricitabine (components of Truvada) concentrations within genital tract of male and females after a single dose of Truvada®. Concentrations of the active drug will be measured in blood (women and men), cervicovaginal aspirates and vaginal tissue (women only), seminal fluid and rectal tissue (men only). Samples will be obtained at 24 hours (1 day), 48 hours (2 days), 5 days, 7 days, 10 days, and 14 days post-dose. Each subject will undergo 2 biopsy days, at least 72 hours apart. Additionally, tissue samples will be evaluated ex-vivo for HIV infectivity.
Primary Outcome
The study aims to examine intra- and extracellular tenofovir and emtricitabine concentrations in various human compartments after a single dose, and to look at the potential for HIV infectivity in tissue samples from these compartments.
Interventions
- DRUG tenofovir + emtricitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2008-10 |
| Est. Completion | 2009-05 |
What the finished NCT01326221 record still lists
NCT01326221 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 12 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which tenofovir + emtricitabine is the first listed.
NCT01326221 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01326221 about?
NCT01326221 is a clinical study titled "Single Dose Truvada in HIV-negative Men and Women". This open-label, non-blinded, pharmacokinetic (PK) study will assess both tenofovir and emtricitabine (components of Truvada) concentrations within genital tract of male and females after a single dose of Truvada®. Concentrations of the active drug will be measured in blood (women and men), cervicov...
What is the current status of trial NCT01326221?
This trial is currently completed. The enrollment target is 12 participants. The study started on 2008-10. Estimated completion is 2009-05.
What interventions are being tested in trial NCT01326221?
The interventions under investigation include: tenofovir + emtricitabine (DRUG).
Who is sponsoring clinical trial NCT01326221?
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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