Changes in Lipids and Safety of Raltegravir in HIV+ Patients With Hyperlipidemia While on Current Standard Therapy

This study has been completed.
Sponsor:
Collaborators:
Tufts Medical Center
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Aadia Rana, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT00887653
First received: April 23, 2009
Last updated: October 8, 2014
Last verified: October 2014
Results First Received: September 19, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV
Hyperlipidemia
Hypertriglyceridemia
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Raltegravir Arm

This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months

raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily.


Participant Flow:   Overall Study
    Raltegravir Arm  
STARTED     20  
COMPLETED     20  
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.
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Reporting Groups
  Description
Raltegravir Arm

This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months

raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily.


Baseline Measures
    Raltegravir Arm  
Number of Participants  
[units: participants]
  20  
Age  
[units: years]
Median ( Full Range )
  52  
  ( 40 to 67 )  
Gender  
[units: participants]
 
Female     3  
Male     17  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     2  
White     16  
More than one race     0  
Unknown or Not Reported     2  
Region of Enrollment  
[units: participants]
 
United States     20  



  Outcome Measures
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1.  Primary:   Change From Baseline Triglycerides   [ Time Frame: 3 months ]

2.  Primary:   Change From Baseline Triglycerides   [ Time Frame: 6 months ]

3.  Secondary:   Proportion of Patients With Plasma Viral Load Below the Limit of Detection   [ Time Frame: 6 months ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Aadia Rana
Organization: THE MIRIAM HOSPITAL
phone: 4017934680
e-mail: arana@lifespan.org


No publications provided


Responsible Party: Aadia Rana, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT00887653     History of Changes
Other Study ID Numbers: 2007-09
Study First Received: April 23, 2009
Results First Received: September 19, 2014
Last Updated: October 8, 2014
Health Authority: United States: Food and Drug Administration