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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
Sponsor:
Information provided by (Responsible Party):

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
  Description
Raltegravir 400 mg twice daily

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



  Baseline Characteristics


  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

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