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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Henry Ford Health System
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Evidence of Toxicity. Toxicity Was Measured as Any Adverse Event; Nausea, Vomiting, Diarrhea. Elevated Liver Function Tests.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Kaletra
Arm 1: Kaletra two tabs twice a day + Truvada one pill once a day.
Intervention: emtricitabine/tenofovir disoproxil fumarate (Drug)
Raltegravir
Arm 2: Raltegravir 400 mg, one pill twice a day + Truvada one pill once a day.
Intervention: emtricitabine/tenofovir disoproxil fumarate (Drug)
Outcomes
Primary Outcomes
Evidence of Toxicity. Toxicity Was Measured as Any Adverse Event; Nausea, Vomiting, Diarrhea. Elevated Liver Function Tests.
Time Frame: Variables to be measured within 4 weeks between groups.
Descriptive study describing toxicity between the 2 groups
Secondary Outcomes
- Number of Participants That Were HIV Infected(HIV ELISA measured within 24 weeks between groups)
Investigators
Indira Brar, MD
Senior Staff Physician Infectious Disease
Henry Ford Health System