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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
History of Changes
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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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 ]
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Measure Type Primary
Measure Title The Percentage of Patients Who Maintain a Viral Load < 50 Copies/ml After Being Switched From Enfuvirtide to Raltegravir
Measure Description evaluate the percent of patients with viral load of <50 copies at week 24 of study after being switched from enfuvirtide to raltegravir
Time Frame 24 weeks  
Safety Issue No  

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.
With expected man baseline residual viremia of 5 copies/ml and predicted standard deviation of 3 in change of residual viremia, our study was predicted to have 80% power to detect a difference of 2.5 copies/ml in residual viremia with =0.05.

Reporting Groups
  Description
Enfuvirtide Switch to Raltegravir Arm patients were switched from Enfuvirtide to Raltegravir

Measured Values
    Enfuvirtide Switch to Raltegravir Arm  
Number of Participants Analyzed  
[units: participants]
 		  14  
The Percentage of Patients Who Maintain a Viral Load < 50 Copies/ml After Being Switched From Enfuvirtide to Raltegravir  
[units: percentage]
 		  86  

No statistical analysis provided for The Percentage of Patients Who Maintain a Viral Load < 50 Copies/ml After Being Switched From Enfuvirtide to Raltegravir




  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Philip Grant, MD
Organization: Stanford University
phone: 650-723-2804
e-mail: pmgrant@stanford.edu


Publications of Results:


Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00523237     History of Changes
Obsolete Identifiers: NCT00627939
Other Study ID Numbers: RAL-eve study
Study First Received: August 29, 2007
Results First Received: July 20, 2011
Last Updated: October 31, 2011
Health Authority: United States: Food and Drug Administration