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Salicylate

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

Phase 2
Waitlist Available
Led By Grace A Mccomsey, M.D.
Research Sponsored by University Hospitals Cleveland Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up entry and week 13 visits
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved

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.

Eligible Conditions
  • Insulin Resistance
  • Inflammation and Pain
  • Inflammation
  • HIV/AIDS
  • Endothelial Dysfunction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~entry and week 13 visits
This trial's timeline: 3 weeks for screening, Varies for treatment, and entry and week 13 visits for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Flow Mediated Dilation (FMD) of the Brachial Artery Measured by Ultrasound Over 13 Weeks

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Active Control
Group I: SalsalateActive Control1 Intervention
Group II: Usual careActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,696 Previous Clinical Trials
4,099,031 Total Patients Enrolled
2 Trials studying Insulin Resistance
51 Patients Enrolled for Insulin Resistance
University Hospitals Cleveland Medical CenterLead Sponsor
330 Previous Clinical Trials
391,646 Total Patients Enrolled
3 Trials studying Insulin Resistance
116 Patients Enrolled for Insulin Resistance
Grace A Mccomsey, M.D.Principal InvestigatorUniversity Hospitals Case Medical Center and Case Western Reserve University
Corrilynn O Hileman, MDPrincipal InvestigatorCase Western Reserve University
2 Previous Clinical Trials
354 Total Patients Enrolled
~2 spots leftby Dec 2025
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