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;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: 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
Fourteen patients, all men, were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All screened patients were enrolled into the study

Reporting Groups
  Description
Raltegravir 400 mg twice daily

Participant Flow:   Overall Study
    Raltegravir  
STARTED     14  
COMPLETED     14  
NOT COMPLETED     0  



  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
Raltegravir 400 mg twice daily

Baseline Measures
    Raltegravir  
Number of Participants  
[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
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Raltegravir 400 mg twice daily

Other Adverse Events
    Raltegravir  
Total, other (not including serious) adverse events    
# participants affected / at risk     0/14  



  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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