Phase 2
Completed N=40
Safety and Efficacy of Salsalate to Treat Endothelial Dysfunction in HIV-infected Adults
Source: ClinicalTrials.gov NCT01046682 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2012
Primary outcomePrimary: Change in Flow Mediated Dilation (FMD) of the Brachial Artery Measured by Ultrasound Over 13 Weeks — 0.99; -0.07 % change from baseline — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Flow Mediated Dilation (FMD) of the Brachial Artery Measured by Ultrasound Over 13 Weeks |
0.99; -0.07 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- HIV-infected
- Evidence of durable virologic suppression, i.e., must have HIV-1 RNA 126 mg/dL or confirmed random glucose level > 200), creatinine clearance 2 upper limit of normal (ULN) within 6 months prior to study entry
Data sourced from ClinicalTrials.gov (NCT01046682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.