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Truvada Plus Raltegravir for Nonoccupational Post-exposure Prophylaxis (nPEP)

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Gilead Sciences
Information provided by (Responsible Party):
Karen Vigil, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01214759
First received: September 30, 2010
Last updated: January 7, 2016
Last verified: January 2016
Results First Received: January 7, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: HIV
Interventions: Drug: Truvada
Drug: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Truvada and Raltegravir

Single arm

Truvada: Tenofovir 200mg/emtricitabine 300mg once a day

Raltegravir: Raltegravir 400mg twice a day


Participant Flow:   Overall Study
    Truvada and Raltegravir  
STARTED     103  
28 Days nPEP Completion     85  
COMPLETED     55  
NOT COMPLETED     48  



  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.
All who were enrolled

Reporting Groups
  Description
Truvada and Raltegravir

Single arm

Truvada: Tenofovir 200mg/emtricitabine 300mg once a day

Raltegravir: Raltegravir 400mg twice a day


Baseline Measures
    Truvada and Raltegravir  
Number of Participants  
[units: participants]
  103  
Age  
[units: years]
Mean (Standard Deviation)
  32  (8.9)  
Gender  
[units: participants]
 
Female     11  
Male     92  
Region of Enrollment  
[units: participants]
 
United States     103  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months   [ Time Frame: 6 months ]

2.  Secondary:   Number of Participants Exhibiting Clinical or Laboratory Abnormalities Resulting From the 28-day Exposure to the Antiretroviral Drugs Being Explored in This Study   [ Time Frame: 28 days ]

3.  Secondary:   Safety and Tolerability as Assessed by the Number of Participants Who Completed the 28-day Course of the Antiretroviral Drugs Being Explored in This Study   [ Time Frame: 28 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
This is a pilot study with a small sample size.


  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. Karen Vigil
Organization: The University of Texas Health Science Center at Houston
phone: (713) 500-6703
e-mail: Karen.J.Vigil@uth.tmc.edu


Publications:

Responsible Party: Karen Vigil, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01214759     History of Changes
Other Study ID Numbers: UT-NPEP
Study First Received: September 30, 2010
Results First Received: January 7, 2016
Last Updated: January 7, 2016
Health Authority: United States: Institutional Review Board