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RAL-eve Study: Raltegravir Substitution Study

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ClinicalTrials.gov Identifier: NCT00523237
Recruitment Status : Completed
First Posted : August 31, 2007
Results First Posted : October 28, 2011
Last Update Posted : November 2, 2011
Information provided by (Responsible Party):
Stanford University

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

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
Raltegravir 400 mg twice daily

Participant Flow:   Overall Study

  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
Raltegravir 400 mg twice daily

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   14 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 56  (56) 
[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

  More Information