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RAL-eve Study: Raltegravir Substitution Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00523237
First received: August 29, 2007
Last updated: October 31, 2011
Last verified: October 2011
Results First Received: July 20, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: Drug: 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.
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Reporting Groups
  Description
Raltegravir 400 mg twice daily

Baseline Measures
   Raltegravir 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   14 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 56  (56) 
Gender 
[Units: Participants]
 
Female   0 
Male   14 
Region of Enrollment 
[Units: Participants]
 
United States   14 


  Outcome Measures

1.  Primary:   The Percentage of Patients Who Maintain a Viral Load < 50 Copies/ml After Being Switched From Enfuvirtide to Raltegravir   [ Time Frame: 24 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
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  More Information