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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)

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ClinicalTrials.gov Identifier: NCT00594646
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : September 10, 2015
Last Update Posted : September 10, 2015
Sponsor:
Collaborator:
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
Enrollment 100

Recruitment Details 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 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.
Arm/Group Title Group 1
Hide Arm/Group Description Men or women, 18 years of age or older, who present within 72 hours of a potential non-occupational exposure to HIV-1.
Period Title: Overall Study
Started 100
Completed 84
Not Completed 16
Reason Not Completed
Withdrawal by Subject             1
Lost to Follow-up             15
Arm/Group Title Group 1
Hide Arm/Group Description TRUVADA (tenofovir DF 300mg + emtricitabine 200mg) + raltegravir (400mg)
Overall Number of Baseline Participants 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
<=18 years
0
   0.0%
Between 18 and 65 years
100
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 100 participants
33.3
(18 to 61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
2
   2.0%
Male
98
  98.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   2.0%
Native Hawaiian or Other Pacific Islander
3
   3.0%
Black or African American
11
  11.0%
White
71
  71.0%
More than one race
13
  13.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 100 participants
100
1.Primary Outcome
Title Medication Regimen Completion Rates
Hide Description Pill counts performed at 14 and 28 days
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1
Hide Arm/Group Description:
TDF 300mg + FTC 200mg (TDF/FTC) once daily + raltegravir 400mg twice daily
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: participants
Completed as perscribed 57
Stopped or Modified regimen 28
Lost to follow-up 15
2.Primary Outcome
Title Number of HIV-1 Infected Participants
Hide Description Of participants that were evaluable at 3 months post initiation of treatment, how many became HIV-1 infected
Time Frame 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants evaluable at 3 months (90 days) after treatment initiation
Arm/Group Title Group 1
Hide Arm/Group Description:
TRUVADA (tenofovir DF 300mg + emtricitabine 200mg) + raltegravir (400mg)
Overall Number of Participants Analyzed 85
Measure Type: Number
Unit of Measure: participants
0
Time Frame 28 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1
Hide Arm/Group Description TDF 300mg and FTC 200mg (TDF/FTC) once daily + raltegravir (400mg) twice daily
All-Cause Mortality
Group 1
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1
Affected / at Risk (%)
Total   0/100 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1
Affected / at Risk (%)
Total   93/100 (93.00%) 
Gastrointestinal disorders   
Diarrhea / Loose Stool / Soft Stool *  21/100 (21.00%) 
Abdominal discomfort, pain, gas, or bloating *  16/100 (16.00%) 
Nausea/vomiting *  27/100 (27.00%) 
Investigations   
Fatigue *  14/100 (14.00%) 
Nervous system disorders   
Headache *  15/100 (15.00%) 
*
Indicates events were collected by non-systematic assessment

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)
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
Responsible Party: Kenneth H. Mayer, MD, Fenway Community Health
ClinicalTrials.gov 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