Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited at 5 clinical centres in Sydney

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A screening period of less than 42 days prior to commencement of study drugs was employed

Reporting Groups
  Description
Drug Intervention Tenofovir+emtricitabine+raltegravir

Participant Flow:   Overall Study
    Drug Intervention  
STARTED     16  
COMPLETED     16  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide 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
  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


  More Information