Post-Exposure Prophylaxis in Health Care Workers (PEP)

Henry Ford Health

Status and phase: Completed; Phase 4

Conditions: Human Immunodeficiency Virus

Treatments: Drug: emtricitabine/tenofovir disoproxil fumarate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01234116

PEP Study

37384 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Kaletra

Active Comparator group

Description:

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

Treatment:

Drug: emtricitabine/tenofovir disoproxil fumarate

Raltegravir

Active Comparator group

Description:

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

Treatment:

Drug: emtricitabine/tenofovir disoproxil fumarate