NCT01046682

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV
• Endothelial Dysfunction
• Inflammation
• Insulin Resistance

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2010-01-12
• Last updated: 2015-01-07
• Results posted: 2012-04-09

Locations

1 site across 1 country: United States