Phase 4
Completed N=16
Post-Exposure Prophylaxis in Health Care Workers
Source: ClinicalTrials.gov NCT01234116 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Evidence of Toxicity. Toxicity Was Measured as Any Adverse Event; Nausea, Vomiting, Diarrhea. Elevated Liver Function Tests. — 4; 4 adverse events
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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. Informational only — not medical advice.