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RAL-eve Study: Raltegravir Substitution Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00523237
First Posted: August 31, 2007
Last Update Posted: November 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stanford University
Results First Submitted: 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
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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 
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
No text entered.


  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: 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
First Submitted: August 29, 2007
First Posted: August 31, 2007
Results First Submitted: July 20, 2011
Results First Posted: October 28, 2011
Last Update Posted: November 2, 2011