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

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