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

Primary Purpose

HIV, Endothelial Dysfunction, Inflammation

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Salsalate

About this trial

This is an interventional treatment trial for HIV focused on measuring HIV, Endothelial dysfunction, Inflammation, Insulin resistance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 years of age or older
HIV-infected
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
On a stable antiretroviral (ARV) regimen, i.e., on the same ARV for at least 12 weeks prior to study entry
No intention to stop or modify ARV regimen during the study period

Exclusion Criteria:

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
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
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
Consumption of alcohol on a daily basis
Active use of illicit drugs
Unable to attend follow-up appointments
Allergy to any salicylic acid-containing medication or salsalate
AST or ALT > 2 upper limit of normal (ULN) within 6 months prior to study entry

Sites / Locations

University Hospitals Case Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Salsalate

Usual care

Arm Description

Outcomes

Primary Outcome Measures

Change in Flow Mediated Dilation (FMD) of the Brachial Artery Measured by Ultrasound Over 13 Weeks

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01046682

First Posted

January 11, 2010

Last Updated

December 18, 2014

Sponsor

University Hospitals Cleveland Medical Center

Collaborators

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT01046682

Brief Title

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

Acronym

Salsalate

Official Title

Assessment of the Use of Salsalate to Decrease Endothelial Cell Activation and Inflammation in HIV-infected Adults

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospitals Cleveland Medical Center

Collaborators

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV, Endothelial Dysfunction, Inflammation, Insulin Resistance

Keywords

HIV, Endothelial dysfunction, Inflammation, Insulin resistance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Salsalate

Arm Type

Active Comparator

Arm Title

Usual care

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

Salsalate

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Flow Mediated Dilation (FMD) of the Brachial Artery Measured by Ultrasound Over 13 Weeks

Description

Time Frame

Entry and week 13 visits

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years of age or older HIV-infected 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 On a stable antiretroviral (ARV) regimen, i.e., on the same ARV for at least 12 weeks prior to study entry No intention to stop or modify ARV regimen during the study period Exclusion Criteria: 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 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 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 Consumption of alcohol on a daily basis Active use of illicit drugs Unable to attend follow-up appointments Allergy to any salicylic acid-containing medication or salsalate AST or ALT > 2 upper limit of normal (ULN) within 6 months prior to study entry

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Grace A Mccomsey, M.D.

Organizational Affiliation

University Hospitals Case Medical Center and Case Western Reserve University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Corrilynn O Hileman, MD

Organizational Affiliation

Case Western Reserve University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospitals Case Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20613460

Citation

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. doi: 10.1097/QAD.0b013e32833c3251.

Results Reference

result

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

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