Post-Exposure Prophylaxis in Health Care Workers

Human Immunodeficiency Virus Clinical Trial

— PEP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01234116
• Other study ID #: PEP Study
• Secondary ID: 37384
• Status: Completed
• Phase: Phase 4
• First received: November 2, 2010
• Last updated: September 26, 2013
• Start date: February 2011
• Est. completion date: May 2013

Study information

• Verified date: September 2013
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Drug:
• emtricitabine/tenofovir disoproxil fumarate
Each health care worker will receive one of the Treatment Arms for 28 days.

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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	Yes