Post-Exposure Prophylaxis in Health Care Workers (PEP)

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

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 Overview

• Status: Completed
• Conditions: Human Immunodeficiency Virus
• Intervention / Treatment: Drug: emtricitabine/tenofovir disoproxil fumarate

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Kaletra; Arm 1: Kaletra two tabs twice a day + Truvada one pill once a day.	Drug: emtricitabine/tenofovir disoproxil fumarate; Each health care worker will receive one of the Treatment Arms for 28 days.; Other Names: Isentress; Truvada; Kaletra
Active Comparator: Raltegravir; Arm 2: Raltegravir 400 mg, one pill twice a day + Truvada one pill once a day.	Drug: emtricitabine/tenofovir disoproxil fumarate; Each health care worker will receive one of the Treatment Arms for 28 days.; Other Names: Isentress; Truvada; Kaletra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evidence of Toxicity. Toxicity Was Measured as Any Adverse Event; Nausea, Vomiting, Diarrhea. Elevated Liver Function Tests.	Descriptive study describing toxicity between the 2 groups	Variables to be measured within 4 weeks between groups.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants That Were HIV Infected	Any patient that gets HIV infected inspite of receiving PEP will be described	HIV ELISA measured within 24 weeks between groups

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Indira Brar, M.D., Henry Ford Health System

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: November 2, 2010
• First Submitted That Met QC Criteria: November 3, 2010
• First Posted (Estimated): November 4, 2010

Study Record Updates

• Last Update Posted (Actual): August 15, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Health Care Workers; Post exposure prophylaxis
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Nucleic Acid Synthesis Inhibitors; Antiviral Agents; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
• Other Study ID Numbers: PEP Study; 37384 (Other Grant/Funding Number: Merck Pharmaceuticals)