Post-Exposure Prophylaxis in Health Care Workers
Status: | Completed |
---|---|
Conditions: | HIV / AIDS |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/2/2013 |
Start Date: | February 2011 |
End Date: | December 2013 |
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.
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.
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
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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