Post-Exposure Prophylaxis in Health Care Workers

Phase 4

Completed

• Conditions: Human Immunodeficiency Virus
• Interventions: Drug: emtricitabine/tenofovir disoproxil fumarate

• Registration Number: NCT01234116
• Lead Sponsor: Henry Ford Health System

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.

Study Timeline

• Study First Submitted: 2010-11-02
• Study First Submitted QC: 2010-11-03
• Study First Posted: 2010-11-04
• Study Start: 2011-02
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-26
• Last Update Posted: 2013-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kaletra	emtricitabine/tenofovir disoproxil fumarate	Arm 1: Kaletra two tabs twice a day + Truvada one pill once a day.
Raltegravir	emtricitabine/tenofovir disoproxil fumarate	Arm 2: Raltegravir 400 mg, one pill twice a day + Truvada one pill once a day.

Primary Outcome Measures

Name	Time	Method
Evidence of toxicity	Variables to be measured within 6 weeks between groups.	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

Name	Time	Method
Evidence of virus transfer	HIV ELISA variables measured within 24 weeks between groups	The presence of virus transfer will be compred between the two groups using ANCOVA models in order to control for demographic and clinical variables.

Trial Locations

Locations (1)

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States