Trial record 5 of 28 for:    " December 12, 2007":" January 11, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

HIV Non Occupational Post-Exposure Prophylaxis (PEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00594646
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : September 10, 2015
Last Update Posted : September 10, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Kenneth H. Mayer, MD, Fenway Community Health

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: HIV Infections
Intervention: Drug: TRUVADA + raltegravir

  Participant Flow

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 
Withdrawal by Subject                1 
Lost to Follow-up                15 

  Baseline Characteristics

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 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   100 
>=65 years   0 
[Units: Years]
Mean (Full Range)
 (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

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

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

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
First Submitted: January 7, 2008
First Posted: January 16, 2008
Results First Submitted: August 10, 2015
Results First Posted: September 10, 2015
Last Update Posted: September 10, 2015