Effect of Raltegravir on Endothelial Function in HIV-Infected Patients

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Priscilla Hsue, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00843713
First received: February 12, 2009
Last updated: May 26, 2015
Last verified: May 2015
Results First Received: January 30, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infection
Inflammation
Cardiovascular Disease
HIV Infections
Interventions: Drug: raltegravir
Drug: Placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo

For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication

Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication

Raltegravir

For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication

raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication


Participant Flow:   Overall Study
    Placebo     Raltegravir  
STARTED     30     26  
COMPLETED     30     26  
NOT COMPLETED     0     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
Placebo

For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication

Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication

Raltegravir

For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication

raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication

Total Total of all reporting groups

Baseline Measures
    Placebo     Raltegravir     Total  
Number of Participants  
[units: participants]
  30     26     56  
Age  
[units: Years]
Mean (Inter-Quartile Range)
  53   (47 to 59)     54   (47 to 59)     53   (47 to 59)  
Gender  
[units: participants]
     
Female     1     2     3  
Male     29     24     53  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     19     20     39  
African-American     5     3     8  
Latino     2     1     3  
Other     4     2     6  



  Outcome Measures

1.  Primary:   Endothelial Function Measured by Brachial Artery Flow-mediated Dilation(FMD)   [ 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
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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: Priscilla Hsue, MD
Organization: University of California, San Francisco
phone: 415-206-8257
e-mail: Priscilla.Hsue@ucsf.edu


No publications provided by University of California, San Francisco

Publications automatically indexed to this study:

Responsible Party: Priscilla Hsue, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00843713     History of Changes
Other Study ID Numbers: 1R01HL095130-01, 1R01HL095130-01
Study First Received: February 12, 2009
Results First Received: January 30, 2015
Last Updated: May 26, 2015
Health Authority: United States: Institutional Review Board