Skip to main content
OpenTrials
Completed

NCT Number: NCT01234116

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 combination with Truvada, as assessed by review of completion rates of PEP and also review of completed safety data.

Completed

Looking for future studies?

Notify Me

Key information

About this study

Health Care Workers that have occupational exposure to blood are at risk for HIV infection. Prevention of blood exposure, through safer practices, barrier precautions, safer needle devices, and other innovations, is the best way to prevent infection with HIV and other bloodborne pathogens.

Though these strategies have been successful in reducing the frequency of blood exposure and needlestick injuries in the past decade, the hazard has not been eliminated. As of December 2001, the CDC had received voluntary reports of 57 documented cases of HIV seroconversion temporally associated with occupational exposure to HIV among U.S. health care personnel. An additional 138 infections among health care personnel were considered possible cases of occupational transmission. Because there is no cure or effective vaccine for HIV, optimal post exposure care, including the administration of antiretroviral drugs to prevent HIV infection, remains a high priority in protecting health care workers.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult (at least 18 years of age)employees of HFH
  • History of occupational exposure to bodily fluids
  • Negative HIV test
  • The ability to understand a written informed consent form, which must be obtained prior to initiation of any study procedures

Exclusion criteria

  • Positive pregnancy test
  • Females who are breastfeeding
  • History of renal disease
  • Contraindication for treating patient with components of PEP regimen
  • Greater than one dose of PEP medication for this exposure event

Treatment and study plan

Emtricitabine/Tenofovir disoproxil fumarate

Drug

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

Other names: Truvada, Isentress, Kaletra

Primary outcomes

  1. Evidence of Toxicity. Toxicity Was Measured as Any Adverse Event; Nausea, Vomiting, Diarrhea. Elevated Liver Function Tests.

    Time frame: Variables to be measured within 4 weeks between groups.

    Descriptive study describing toxicity between the 2 groups

Secondary outcomes

  1. Number of Participants That Were HIV Infected

    Time frame: HIV ELISA measured within 24 weeks between groups

    Any patient that gets HIV infected inspite of receiving PEP will be described

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Acronym: PEP

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 4, 2010
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.