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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: Completed Phase 4 study of Human Immunodeficiency Virus, sponsored by Henry Ford Health System.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Descriptive study describing toxicity between the 2 groups
Conditions Studied
Interventions
- DRUG emtricitabine/tenofovir disoproxil fumarate
Study Locations (1)
Michigan
- Henry Ford Hospital - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2011-02 |
| Est. Completion | 2013-05 |
| Phase | Phase 4 |
What the finished NCT01234116 record still lists
NCT01234116 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 184-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (91% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT01234116's enrollment target sits among peer trials
16 36th of 39 higher than 3 of 39 other Human Immunodeficiency Virus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Human Immunodeficiency Virus 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.
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