Post-Exposure Prophylaxis in Health Care Workers (PEP)
Primary Purpose
Human Immunodeficiency Virus
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
emtricitabine/tenofovir disoproxil fumarate
Sponsored by
About this trial
This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring Post exposure prophylaxis, Health Care Workers
Eligibility Criteria
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
Sites / Locations
- Henry Ford Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Kaletra
Raltegravir
Arm Description
Arm 1: Kaletra two tabs twice a day + Truvada one pill once a day.
Arm 2: Raltegravir 400 mg, one pill twice a day + Truvada one pill once a day.
Outcomes
Primary Outcome Measures
Evidence of toxicity
The main outcomes of toxicity will be compared between the two groups using ANCOVA models in order to control for demographic and clinical variables.
Secondary Outcome Measures
Evidence of virus transfer
The presence of virus transfer will be compred between the two groups using ANCOVA models in order to control for demographic and clinical variables.
Full Information
NCT ID
NCT01234116
First Posted
November 2, 2010
Last Updated
September 26, 2013
Sponsor
Henry Ford Health System
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01234116
Brief Title
Post-Exposure Prophylaxis in Health Care Workers
Acronym
PEP
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
Post exposure prophylaxis, Health Care Workers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kaletra
Arm Type
Active Comparator
Arm Description
Arm 1: Kaletra two tabs twice a day + Truvada one pill once a day.
Arm Title
Raltegravir
Arm Type
Active Comparator
Arm Description
Arm 2: Raltegravir 400 mg, one pill twice a day + Truvada one pill once a day.
Intervention Type
Drug
Intervention Name(s)
emtricitabine/tenofovir disoproxil fumarate
Other Intervention Name(s)
Truvada, Isentress, Kaletra
Intervention Description
Each health care worker will receive one of the Treatment Arms for 28 days.
Primary Outcome Measure Information:
Title
Evidence of toxicity
Description
The main outcomes of toxicity will be compared between the two groups using ANCOVA models in order to control for demographic and clinical variables.
Time Frame
Variables to be measured within 6 weeks between groups.
Secondary Outcome Measure Information:
Title
Evidence of virus transfer
Description
The presence of virus transfer will be compred between the two groups using ANCOVA models in order to control for demographic and clinical variables.
Time Frame
HIV ELISA variables measured within 24 weeks between groups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Indira Brar, M.D.
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Post-Exposure Prophylaxis in Health Care Workers
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