Phase 4
N=16
Post-Exposure Prophylaxis in Health Care Workers
Human Immunodeficiency Virus
Bottom Line
View on ClinicalTrials.gov: NCT01234116 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Evidence of Toxicity. Toxicity Was Measured as Any Adverse Event; Nausea, Vomiting, Diarrhea. Elevated Liver Function Tests. — 4; 4 adverse events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- emtricitabine/tenofovir disoproxil fumarate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Henry Ford Health System
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evidence of Toxicity. Toxicity Was Measured as Any Adverse Event; Nausea, Vomiting, Diarrhea. Elevated Liver Function Tests. |
4; 4 | — |
| SECONDARY Number of Participants That Were HIV Infected |
0; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01234116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.