NCT01234116

Post-Exposure Prophylaxis in Health Care Workers

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	emtricitabine/tenofovir disoproxil fumarate	Each health care worker will receive one of the Treatment Arms for 28 days.

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2010-11-04
• Last updated: 2025-08-15
• Results posted: 2025-08-15

Locations

1 site across 1 country: United States