Post-Exposure Prophylaxis in Health Care Workers

NCT ID: NCT01234116

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-05-31

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.

Conditions

Human Immunodeficiency Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Kaletra

Arm 1: Kaletra two tabs twice a day + Truvada one pill once a day.

Group Type: ACTIVE_COMPARATOR

emtricitabine/tenofovir disoproxil fumarate

Intervention Type: DRUG

Each health care worker will receive one of the Treatment Arms for 28 days.

Raltegravir

Arm 2: Raltegravir 400 mg, one pill twice a day + Truvada one pill once a day.

Group Type: ACTIVE_COMPARATOR

emtricitabine/tenofovir disoproxil fumarate

Intervention Type: DRUG

Each health care worker will receive one of the Treatment Arms for 28 days.

Interventions

emtricitabine/tenofovir disoproxil fumarate

Each health care worker will receive one of the Treatment Arms for 28 days.

Intervention Type: DRUG

Other Intervention Names

Truvada; Isentress; Kaletra

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Indira Brar, MD

Senior Staff Physician Infectious Disease

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Indira Brar, M.D.

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

Henry Ford Hospital

Detroit, Michigan, United States

Countries

United States

Other Identifiers

37384

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PEP Study

Identifier Type: -

Identifier Source: org_study_id