Post-Exposure Prophylaxis in Health Care Workers

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Human Immunodeficiency Virus

Intervention / Treatment
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* Drug: emtricitabine/tenofovir disoproxil fumarate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Kaletra<br>Arm 1: Kaletra two tabs twice a day + Truvada one pill once a day. | Drug: emtricitabine/tenofovir disoproxil fumarate<br>* Each health care worker will receive one of the Treatment Arms for 28 days.<br>* Other names: Kaletra;|
| Active Comparator: Raltegravir<br>Arm 2: Raltegravir 400 mg, one pill twice a day + Truvada one pill once a day. | Drug: emtricitabine/tenofovir disoproxil fumarate<br>* Each health care worker will receive one of the Treatment Arms for 28 days.<br>* Other names: Kaletra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Variables to be measured within 6 weeks between groups. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | HIV ELISA variables measured within 24 weeks between groups | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post exposure prophylaxis, Health Care Workers