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The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection (PINT)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
CSajjadi, Kirby Institute
ClinicalTrials.gov Identifier:
NCT00641641
First received: February 28, 2008
Last updated: May 23, 2013
Last verified: May 2013
Results First Received: April 11, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infection
Intervention: Drug: Tenofovir + emtricitabine + raltegravir.

  Participant Flow


  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
  Description
Drug Intervention Tenofovir+emtricitabine+raltegravir

Baseline Measures
    Drug Intervention  
Number of Participants  
[units: participants]
  16  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     16  
>=65 years     0  
Gender  
[units: participants]
 
Female     0  
Male     16  
Region of Enrollment  
[units: participants]
 
Australia     16  



  Outcome Measures

1.  Primary:   Mean Change From Baseline Plasma HIV RNA (Log Copies/mL)   [ Time Frame: 12 times within 48 weeks. ]


  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
Limited cohort (n=16) of exclusively male participants treated with a licensed regimen of combination antiretroviral therapy with the primary focus being a detailed examination of virus decay characteristics


  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: Sean Emery
Organization: University of New South Wales
phone: 9385 0900
e-mail: semery@kirby.unsw.edu.au


Publications of Results:

Responsible Party: CSajjadi, Kirby Institute
ClinicalTrials.gov Identifier: NCT00641641     History of Changes
Other Study ID Numbers: PINT01
Study First Received: February 28, 2008
Results First Received: April 11, 2012
Last Updated: May 23, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration