HIV Non Occupational Post-Exposure Prophylaxis (PEP)

This study has been completed.
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Kenneth H. Mayer, MD, Fenway Community Health Identifier:
First received: January 7, 2008
Last updated: August 10, 2015
Last verified: August 2015
Results First Received: August 10, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: HIV Infections
Intervention: Drug: TRUVADA + raltegravir

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from Fenway Health. Patients at least 18 years of age, who contacted Fenway Health and presented within 72 hours after a potential sexual exposure to HIV-1 were asked to participate in this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
If study coordinator is notified more than 72 hours after exposure occurred, person will not be eligible for study participation; however they will be referred to an on call medical provider for Non Occupational Post-Exposure Prophylaxis evaluation.

Reporting Groups
Group 1 Men or women, 18 years of age or older, who present within 72 hours of a potential non-occupational exposure to HIV-1.

Participant Flow:   Overall Study
    Group 1  
STARTED     100  
COMPLETED     84  
Withdrawal by Subject                 1  
Lost to Follow-up                 15  

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Group 1 TRUVADA (tenofovir DF 300mg + emtricitabine 200mg) + raltegravir (400mg)

Baseline Measures
    Group 1  
Number of Participants  
[units: participants]
[units: participants]
<=18 years     0  
Between 18 and 65 years     100  
>=65 years     0  
[units: years]
Mean (Full Range)
  33.3   (18 to 61)  
[units: participants]
Female     2  
Male     98  
Race (NIH/OMB)  
[units: participants]
American Indian or Alaska Native     0  
Asian     2  
Native Hawaiian or Other Pacific Islander     3  
Black or African American     11  
White     71  
More than one race     13  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
United States     100  

  Outcome Measures
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1.  Primary:   Medication Regimen Completion Rates   [ Time Frame: 28 days ]

2.  Primary:   Number of HIV-1 Infected Participants   [ Time Frame: 90 days ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

Limitations of the current study included:

  1. Reliance on self-reports to measure adherence
  2. Study population almost exclusively male (reflecting the demographics of people who call Fenway Health's hotline after an acute sexual exposure)

  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. Kenneth Mayer
Organization: Fenway Health
phone: 617-927-6400

Publications of Results:

Responsible Party: Kenneth H. Mayer, MD, Fenway Community Health Identifier: NCT00594646     History of Changes
Other Study ID Numbers: MK PEP 2007
Study First Received: January 7, 2008
Results First Received: August 10, 2015
Last Updated: August 10, 2015
Health Authority: United States: Food and Drug Administration