Human Immunodeficiency VirusPhase 4PEPNCT01234116
Post-Exposure Prophylaxis in Health Care Workers
A Phase 4 study testing emtricitabine/tenofovir disoproxil fumarate in people with Human Immunodeficiency Virus, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- emtricitabine/tenofovir disoproxil fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to May 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- emtricitabine/tenofovir disoproxil fumarate
- Keywords
- Post exposure prophylaxis, Health Care Workers
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emtricitabine/tenofovir disoproxil fumarateDrug
Also called Truvada, Isentress, Kaletra
Each health care worker will receive one of the Treatment Arms for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Kaletra | Active comparator | Arm 1: Kaletra two tabs twice a day + Truvada one pill once a day. Receives: Drug: emtricitabine/tenofovir disoproxil fumarate |
| Raltegravir | Active comparator | Arm 2: Raltegravir 400 mg, one pill twice a day + Truvada one pill once a day. Receives: Drug: emtricitabine/tenofovir disoproxil fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of Toxicity. Toxicity Was Measured as Any Adverse Event; Nausea, Vomiting, Diarrhea. Elevated Liver Function Tests.
Descriptive study describing toxicity between the 2 groups
Measured: Variables to be measured within 4 weeks between groups.
Secondary outcomes (1)
Number of Participants That Were HIV Infected
Any patient that gets HIV infected inspite of receiving PEP will be described
Measured: HIV ELISA measured within 24 weeks between groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startFeb 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Indira Brar, MD, Henry Ford Health System
- Investigators
- Indira Brar, M.D., Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234116
- Sponsor's protocol ID
- PEP Study
- Other IDs
- 37384
- Acronym
- PEP
- Status last verified
- Jul 2025
- First submitted
- 2 Nov 2010
- Last updated
- 15 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01234116
- Acronym / sponsor ID
- PEP / PEP Study
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Post exposure prophylaxis, Health Care Workers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Feb 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 4 Nov 2010 (estimated)
- Results
- Posted 15 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kaletra | Active comparator | Drug: emtricitabine/tenofovir disoproxil fumarateArm 1: Kaletra two tabs twice a day + Truvada one pill once a day. |
| Raltegravir | Active comparator | Drug: emtricitabine/tenofovir disoproxil fumarateArm 2: Raltegravir 400 mg, one pill twice a day + Truvada one pill once a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| emtricitabine/tenofovir disoproxil fumarateAlso: Truvada, Isentress, KaletraEach health care worker will receive one of the Treatment Arms for 28 days. | Drug | Kaletra, Raltegravir |
Primary outcome
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
1 secondary outcome
Number of Participants That Were HIV Infected
Time frame: HIV ELISA measured within 24 weeks between groups
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Indira Brar, M.D. principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing emtricitabine/tenofovir disoproxil fumarate in people with Human Immunodeficiency Virus, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.