Safety and Efficacy of Salsalate to Treat Endothelial Dysfunction in HIV-infected Adults

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Grace McComsey, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01046682
First received: January 11, 2010
Last updated: May 14, 2012
Last verified: May 2012
Results First Received: March 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV
Endothelial Dysfunction
Inflammation
Insulin Resistance
Intervention: Drug: Salsalate

  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
Salsalate Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
Usual Care No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.

Participant Flow:   Overall Study
    Salsalate     Usual Care  
STARTED     20     20  
COMPLETED     18     20  
NOT COMPLETED     2     0  
Adverse Event                 2                 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
Salsalate Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
Usual Care No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
Total Total of all reporting groups

Baseline Measures
    Salsalate     Usual Care     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     20     20     40  
>=65 years     0     0     0  
Age  
[units: years]
Median ( Inter-Quartile Range )
  46.5  
  ( 42.5 to 49 )  
  46  
  ( 44 to 52.5 )  
  46  
  ( 43.5 to 50 )  
Gender  
[units: participants]
     
Female     2     0     2  
Male     18     20     38  
Region of Enrollment  
[units: participants]
     
United States     20     20     40  



  Outcome Measures

1.  Primary:   Change in Flow Mediated Dilation (FMD) of the Brachial Artery Measured by Ultrasound Over 13 Weeks   [ Time Frame: Entry and week 13 visits ]


  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
Lack of placebo in the control group precluded blinding of the study investigators. Adherence was measured utilizing pill counts which assumes that pills not returned were taken by the participant. Sample size too small to detect a small effect.


  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: Grace McComsey, MC
Organization: UHospitalsCleveland
phone: 216-844-3607
e-mail: mccomsey.grace@clevelandactu.org


Publications of Results:

Responsible Party: Grace McComsey, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01046682     History of Changes
Other Study ID Numbers: 02-08-02
Study First Received: January 11, 2010
Results First Received: March 12, 2012
Last Updated: May 14, 2012
Health Authority: United States: Food and Drug Administration