Post-Exposure Prophylaxis in Health Care Workers (PEP)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Human Immunodeficiency Virus	Drug: emtricitabine/tenofovir disoproxil fumarate	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	16 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	February 2011
Actual Primary Completion Date :	May 2013
Actual Study Completion Date :	May 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Kaletra; Arm 1: Kaletra two tabs twice a day + Truvada one pill once a day.	Drug: emtricitabine/tenofovir disoproxil fumarate; Each health care worker will receive one of the Treatment Arms for 28 days.; Other Names: Truvada; Isentress; Kaletra
Active Comparator: Raltegravir; Arm 2: Raltegravir 400 mg, one pill twice a day + Truvada one pill once a day.	Drug: emtricitabine/tenofovir disoproxil fumarate; Each health care worker will receive one of the Treatment Arms for 28 days.; Other Names: Truvada; Isentress; Kaletra

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Evidence of toxicity [ Time Frame: 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 :

1. Evidence of virus transfer [ Time Frame: 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202

Sponsors and Collaborators

Henry Ford Health System

Merck Sharp & Dohme Corp.

Investigators

Principal Investigator:	Indira Brar, M.D.	Henry Ford Health System

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Indira Brar, MD, Senior Staff Physician Infectious Disease, Henry Ford Health System
ClinicalTrials.gov Identifier:	NCT01234116 History of Changes
Other Study ID Numbers:	PEP Study; 37384 ( Other Grant/Funding Number: Merck Pharmaceuticals )
First Posted:	November 4, 2010
Last Update Posted:	September 27, 2013
Last Verified:	September 2013

Keywords provided by Indira Brar, MD, Henry Ford Health System:

Post exposure prophylaxis; Health Care Workers

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Slow Virus Diseases; Tenofovir; Raltegravir Potassium; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination	Lopinavir; Antiviral Agents; Anti-Infective Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Retroviral Agents; Anti-HIV Agents; HIV Integrase Inhibitors; Integrase Inhibitors; HIV Protease Inhibitors; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors