drugset / Trial / NCT01046682
Safety and Efficacy of Salsalate to Treat Endothelial Dysfunction in HIV-infected Adults
Phase 2
Completed
40 enrolled
University Hospitals Cleveland Medical Center
Bristol-Myers Squibb · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2009-01
- Primary completion
- 2009-07
- Completion
- 2009-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Salsalate | Small molecule | 2 g | Oral |