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
2 other identifiers
interventional
16
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2011
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2010
CompletedFirst Posted
Study publicly available on registry
November 4, 2010
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
August 15, 2025
CompletedAugust 15, 2025
July 1, 2025
2.2 years
November 2, 2010
April 3, 2023
July 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of Participants That Were HIV Infected
HIV ELISA measured within 24 weeks between groups
Study Arms (2)
Kaletra
ACTIVE COMPARATORArm 1: Kaletra two tabs twice a day + Truvada one pill once a day.
Raltegravir
ACTIVE COMPARATORArm 2: Raltegravir 400 mg, one pill twice a day + Truvada one pill once a day.
Interventions
Each health care worker will receive one of the Treatment Arms for 28 days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Henry Ford Health Systemlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
Henry Ford Hospital
Detroit, Michigan, 48202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Indira Brar, MD
- Organization
- Henry Ford Health Sytem
Study Officials
- PRINCIPAL INVESTIGATOR
Indira Brar, M.D.
Henry Ford Health System
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Staff Physician Infectious Disease
Study Record Dates
First Submitted
November 2, 2010
First Posted
November 4, 2010
Study Start
February 1, 2011
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
August 15, 2025
Results First Posted
August 15, 2025
Record last verified: 2025-07