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Post-Exposure Prophylaxis in Health Care Workers (PEP)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Indira Brar, MD, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01234116
First received: November 2, 2010
Last updated: September 26, 2013
Last verified: September 2013

November 2, 2010
September 26, 2013
February 2011
May 2013   (final data collection date for primary outcome measure)
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 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 btween the two groups using ANCOVA models in order to control for demographic and clinical variables.
Complete list of historical versions of study NCT01234116 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Post-Exposure Prophylaxis in Health Care Workers
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Human Immunodeficiency Virus
Drug: emtricitabine/tenofovir disoproxil fumarate
Each health care worker will receive one of the Treatment Arms for 28 days.
Other Names:
  • Truvada
  • Isentress
  • Kaletra
  • Active Comparator: Kaletra
    Arm 1: Kaletra two tabs twice a day + Truvada one pill once a day.
    Intervention: Drug: emtricitabine/tenofovir disoproxil fumarate
  • Active Comparator: Raltegravir
    Arm 2: Raltegravir 400 mg, one pill twice a day + Truvada one pill once a day.
    Intervention: Drug: emtricitabine/tenofovir disoproxil fumarate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01234116
PEP Study, 37384
No
Indira Brar, MD, Henry Ford Health System
Henry Ford Health System
Merck Sharp & Dohme Corp.
Principal Investigator: Indira Brar, M.D. Henry Ford Health System
Henry Ford Health System
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP