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Post-Exposure Prophylaxis in Health Care Workers (PEP)

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ClinicalTrials.gov Identifier: NCT01234116
Recruitment Status : Completed
First Posted : November 4, 2010
Last Update Posted : September 27, 2013
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Indira Brar, MD, Henry Ford Health System

Study Description
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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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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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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01234116


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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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    Key Record Dates
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