Post-Exposure Prophylaxis in Health Care Workers

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Henry Ford Health System
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lopinavir; Raltegravir Potassium; Tenofovir

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