Post-Exposure Prophylaxis in Health Care Workers (PEP)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Human Immunodeficiency Virus |
Drug: emtricitabine/tenofovir disoproxil fumarate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Evidence of toxicity [ Time Frame: Variables to be measured within 6 weeks between groups. ] [ Designated as safety issue: Yes ]The main outcomes of toxicity will be compared between the two groups using ANCOVA models in order to control for demographic and clinical variables.
- Evidence of virus transfer [ Time Frame: HIV ELISA variables measured within 24 weeks between groups ] [ Designated as safety issue: Yes ]The presence of virus transfer will be compred between the two groups using ANCOVA models in order to control for demographic and clinical variables.
| Enrollment: | 16 |
| Study Start Date: | February 2011 |
| Study Completion Date: | May 2013 |
| Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Kaletra
Arm 1: Kaletra two tabs twice a day + Truvada one pill once a day.
|
Drug: emtricitabine/tenofovir disoproxil fumarate
Each health care worker will receive one of the Treatment Arms for 28 days.
Other Names:
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Active Comparator: Raltegravir
Arm 2: Raltegravir 400 mg, one pill twice a day + Truvada one pill once a day.
|
Drug: emtricitabine/tenofovir disoproxil fumarate
Each health care worker will receive one of the Treatment Arms for 28 days.
Other Names:
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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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01234116
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| Principal Investigator: | Indira Brar, M.D. | Henry Ford Health System |
More Information
| Responsible Party: | Indira Brar, MD, Senior Staff Physician Infectious Disease, Henry Ford Health System |
| ClinicalTrials.gov Identifier: | NCT01234116 History of Changes |
| Other Study ID Numbers: | PEP Study 37384 |
| Study First Received: | November 2, 2010 |
| Last Updated: | September 26, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Henry Ford Health System:
|
Post exposure prophylaxis Health Care Workers |
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Raltegravir Potassium Tenofovir Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Lopinavir |
Emtricitabine Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors Protease Inhibitors Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |
ClinicalTrials.gov processed this record on September 30, 2016