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NCT03270969 · ClinicalTrials.gov registry record · Phase 1

A Pharmacokinetic Evaluation of Tenofovir/Emtricitabine as HIV Pre-Exposure Prophylaxis in Transgender Women

A Phase 1 study, sponsored by University of Nebraska.

Completed
Registry status
Phase 1
Development phase
15
Enrollment target

NCT03270969: Completed Phase 1 study, sponsored by University of Nebraska.

NCT03270969 is a Phase 1 study that has completed, run by University of Nebraska. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03270969, a Phase 1 study, has completed, sponsored by University of Nebraska.

COMPLETED
Registry status
Phase 1
Development phase
15 participants
Enrollment target

Study Summary

Human immunodeficiency virus (HIV) persists worldwide as an immense health burden among vulnerable populations. HIV pre-exposure prophylaxis (PrEP) has offered the promise of limiting the global burden of HIV. The objective of this proposal is to conduct a pharmacokinetic (PK) study in transgender women to describe the pharmacokinetics of tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) as PrEP within this population.

Primary Outcome

Intensive PK sampling compared to historical controls

Interventions

  • DRUG Tenofovir Disoproxil Fumarate/Emtricitabine

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2018-01-05
Est. Completion 2018-09-10
Phase Phase 1
University of Nebraska

407 total trials

What the finished NCT03270969 record still lists

NCT03270969 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).

The record links to 0 conditions, and to 1 intervention - of which Tenofovir Disoproxil Fumarate/Emtricitabine is the first listed.

NCT03270969 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03270969 about?

NCT03270969 is a clinical study titled "A Pharmacokinetic Evaluation of Tenofovir/Emtricitabine as HIV Pre-Exposure Prophylaxis in Transgender Women". Human immunodeficiency virus (HIV) persists worldwide as an immense health burden among vulnerable populations. HIV pre-exposure prophylaxis (PrEP) has offered the promise of limiting the global burden of HIV. The objective of this proposal is to conduct a pharmacokinetic (PK) study in transgender w...

What is the current status of trial NCT03270969?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2018-01-05. Estimated completion is 2018-09-10.

What interventions are being tested in trial NCT03270969?

The interventions under investigation include: Tenofovir Disoproxil Fumarate/Emtricitabine (DRUG).

Who is sponsoring clinical trial NCT03270969?

This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03270969's enrollment target sits among peer trials

15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT03270969, the US trial registry maintained by the National Library of Medicine. NCT03270969 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.