Clinical trial NCT01234116: Post-Exposure Prophylaxis in Health Care Workers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Human Immunodeficiency Virus
Keywords: Post exposure prophylaxis
Health Care Workers
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2010-11-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Evidence of toxicity
timeFrame: Variables to be measured within 6 weeks between groups.
Secondary outcomes:
measure: Evidence of virus transfer
timeFrame: HIV ELISA variables measured within 24 weeks between groups
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Indira Brar, M.D.
role: PRINCIPAL_INVESTIGATOR
References: