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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01046682
Recruitment Status : Completed
First Posted : January 12, 2010
Results First Posted : April 9, 2012
Last Update Posted : January 7, 2015
Bristol-Myers Squibb
Information provided by (Responsible Party):
Grace McComsey, University Hospitals Cleveland Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Endothelial Dysfunction Inflammation Insulin Resistance Drug: Salsalate Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of the Use of Salsalate to Decrease Endothelial Cell Activation and Inflammation in HIV-infected Adults
Study Start Date : January 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Salsalate 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.

No Intervention: Usual care

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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01046682

United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
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

Publications of Results:
Responsible Party: Grace McComsey, Principal Investigator, University Hospitals Cleveland Medical Center Identifier: NCT01046682     History of Changes
Other Study ID Numbers: 02-08-02
First Posted: January 12, 2010    Key Record Dates
Results First Posted: April 9, 2012
Last Update Posted: January 7, 2015
Last Verified: December 2014

Keywords provided by Grace McComsey, University Hospitals Cleveland Medical Center:
Endothelial dysfunction
Insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Salicylsalicylic acid
Sodium Salicylate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action