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NCT01234116 · ClinicalTrials.gov registry record · Phase 4

Post-Exposure Prophylaxis in Health Care Workers

A Phase 4 study of Human Immunodeficiency Virus, sponsored by Henry Ford Health System.

Completed
Registry status
Phase 4
Development phase
16
Enrollment target
1
Study location

NCT01234116 is a Phase 4 study of Human Immunodeficiency Virus that has completed, run by Henry Ford Health System. The registered enrollment target is 16 participants, below the 184-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01234116, a Phase 4 study of Human Immunodeficiency Virus, has completed, sponsored by Henry Ford Health System.

COMPLETED
Registry status
Phase 4
Development phase
16 participants
Enrollment target
1
Study location

Study Summary

Objective: The objective of this study is to determine the safety and tolerability of Post-exposure Prophylaxis (PEP) with a regimen of Truvada + Kaletra among health care workers (HCWs) at Henry Ford Hospital. Hypothesis: Raltegravir is safe and better tolerated compared with Kaletra, each in combination with Truvada, as assessed by review of completion rates of PEP and also review of completed safety data.

Interventions

  • DRUG emtricitabine/tenofovir disoproxil fumarate

Study Locations (1)

Michigan

  • Henry Ford Hospital - Detroit

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2011-02
Est. Completion 2013-05
Phase Phase 4

Sponsor

Henry Ford Health System

234 total trials

What the Registry Record Tells You About NCT01234116

The ClinicalTrials.gov registry entry for NCT01234116 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 184-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (91% lower). The listed sponsor is Henry Ford Health System, which has 234 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Human Immunodeficiency Virus appearing as the primary indexed condition, and to 1 intervention - of which emtricitabine/tenofovir disoproxil fumarate is the first listed.

NCT01234116 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.

Frequently Asked Questions

What is clinical trial NCT01234116 about?

NCT01234116 is a clinical study titled "Post-Exposure Prophylaxis in Health Care Workers". Objective: The objective of this study is to determine the safety and tolerability of Post-exposure Prophylaxis (PEP) with a regimen of Truvada + Kaletra among health care workers (HCWs) at Henry Ford Hospital. Hypothesis: Raltegravir is safe and better tolerated compared with Kaletra, each in comb...

What is the current status of trial NCT01234116?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2011-02. Estimated completion is 2013-05.

What conditions does trial NCT01234116 study?

This clinical trial studies the following conditions: Human Immunodeficiency Virus.

What interventions are being tested in trial NCT01234116?

The interventions under investigation include: emtricitabine/tenofovir disoproxil fumarate (DRUG).

Who is sponsoring clinical trial NCT01234116?

This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01234116 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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