CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 16 enrolled
Drug / intervention
emtricitabine/tenofovir disoproxil fumaratedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01234116
NCT01234116Phase 4Completed
CompareCT.gov

A Prospective, Randomized, Open Label Study to Evaluate the Safety and Tolerability of Raltegravir + Truvada Versus Kaletra + Truvada, for Post-exposure Prophylaxis in Health Care Workers

Henry Ford Health System·interventional·Posted Nov 4, 2010·Updated Aug 15, 2025

In Brief

A Phase 4 clinical trial evaluating emtricitabine/tenofovir disoproxil fumarate for Human Immunodeficiency Virus. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Immunodeficiency Virus
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 4, 2010
Enrollment StartFeb 1, 2011
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.7 years ago

Interventions

emtricitabine/tenofovir disoproxil fumaratedrug

Each health care worker will receive one of the Treatment Arms for 28 days.