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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01234116 |
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Date of registration:
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02/11/2010 |
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Primary sponsor: |
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Public title:
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Post-Exposure Prophylaxis in Health Care Workers
PEP |
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Scientific title:
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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 |
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Date of first enrolment:
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February 2011 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01234116 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Jonathan Clemmer, R.N. |
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Address:
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Telephone:
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313-916-3451 |
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Email:
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jclemme1@hfhs.org |
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Affiliation:
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Name:
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Indira Brar, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Henry Ford Health System |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Human Immunodeficiency Virus
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Intervention(s)
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Drug: emtricitabine/tenofovir disoproxil fumarate
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Primary Outcome(s)
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Evidence of toxicity
[Time Frame: Variables to be measured within 6 weeks between groups.]
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Secondary Outcome(s)
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Evidence of virus transfer
[Time Frame: HIV ELISA variables measured within 24 weeks between groups]
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Secondary ID(s)
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37384
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PEP Study
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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