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

January 11, 2010
May 14, 2012
January 2009
July 2009   (final data collection date for primary outcome measure)
Change in Flow Mediated Dilation (FMD) of the Brachial Artery Measured by Ultrasound Over 13 Weeks [ Time Frame: Entry and week 13 visits ] [ Designated as safety issue: No ]
Flow mediated dilation (FMD) of the brachial artery was measured by ultrasound. This is a measure of endothelial dependent endothelial cell function. Flow mediated dilation is expressed as a percent change from baseline brachial artery diameter to brachial artery diameter after reactive hyperemia. Reactive hyperemia occurred after occluding the brachial artery with a blood pressure cuff for 5 minutes.
Flow mediated dilation of the brachial artery measured by ultrasound [ Time Frame: Entry and week 13 visits ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01046682 on ClinicalTrials.gov Archive Site
Not Provided
Insulin resistance, measured by fasting glucose and insulin [ Time Frame: Entry and week 13 visits ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of Salsalate to Treat Endothelial Dysfunction in HIV-infected Adults
Assessment of the Use of Salsalate to Decrease Endothelial Cell Activation and Inflammation in HIV-infected Adults

This is a phase II, open label, randomized-controlled pilot study designed to study both the efficacy and safety of salsalate in decreasing endothelial cell dysfunction, systemic inflammation, and insulin resistance in HIV-infected adults. The investigators hypothesis is that salsalate will reduce inflammation and therefore endothelial cell activation and insulin resistance. The sample size will be 40, with an equal number of people being randomized to one of two groups. The first arm will be randomized to salsalate therapy. The second arm will act as a control group. The study duration will be 13 weeks.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • HIV
  • Endothelial Dysfunction
  • Inflammation
  • Insulin Resistance
Drug: Salsalate
Salsalate 2 grams orally twice a day for 13 weeks. This is the maximum dosage. During the initial 9 days of the study salsalate dose will be titrated to reach this goal dosage.
  • Active Comparator: Salsalate
    Intervention: Drug: Salsalate
  • No Intervention: Usual care
Hileman CO, Carman TL, Gripshover BM, O'Riordan M, Storer NJ, Harrill DE, White CA, McComsey GA. Salsalate is poorly tolerated and fails to improve endothelial function in virologically suppressed HIV-infected adults. AIDS. 2010 Jul 31;24(12):1958-61.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 18 years of age or older
  2. HIV-infected
  3. Evidence of durable virologic suppression, i.e., must have HIV-1 RNA < 400 copies/ml at study entry and for at least 12 weeks prior to entry
  4. On a stable antiretroviral (ARV) regimen, i.e., on the same ARV for at least 12 weeks prior to study entry
  5. No intention to stop or modify ARV regimen during the study period

Exclusion Criteria:

  1. Current pregnancy or breast feeding, or women of child bearing age who refuse or are unable to use appropriate methods for contraception during the study period
  2. Any of the following conditions: diabetes (2 fasting glucose levels > 126 mg/dL or confirmed random glucose level > 200), creatinine clearance < 50, aspirin-sensitive asthma, COPD, history of bleeding gastric or duodenal ulcer, hepatic dysfunction, active hepatitis B or C, and any active infectious or inflammatory condition
  3. Need for regular use of any of the following medications: salsalate, aspirin, non-steroidal antiinflammatories (NSAIDS), corticosteroids, warfarin or other anticoagulation therapy, phenytoin, valproic acid, carbonic anhydrase inhibitors, lithium, probenecid or sulfinpyrazone
  4. Consumption of alcohol on a daily basis
  5. Active use of illicit drugs
  6. Unable to attend follow-up appointments
  7. Allergy to any salicylic acid-containing medication or salsalate
  8. AST or ALT > 2 upper limit of normal (ULN) within 6 months prior to study entry
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01046682
02-08-02
No
Grace McComsey, University Hospitals of Cleveland
University Hospitals of Cleveland
Bristol-Myers Squibb
Principal Investigator: Grace A Mccomsey, M.D. University Hospitals Case Medical Center and Case Western Reserve University
Principal Investigator: Corrilynn O Hileman, MD Case Western Reserve University
University Hospitals of Cleveland
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP