Safety and Efficacy of Salsalate to Treat Endothelial Dysfunction in HIV-infected Adults
Condition: HIV; Endothelial Dysfunction; Inflammation; Insulin Resistance
MeSH terms: Insulin Resistance; Inflammation
Intervention: Salsalate
Intervention description: 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.
Intervention MeSH terms: Salicylsalicylic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; Endothelial dysfunction; Inflammation; Insulin resistance

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age or older

          2. HIV-infected

          3. 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

          4. On a stable antiretroviral (ARV) regimen, i.e., on the same ARV for at least 12 weeks
             prior to study entry

          5. No intention to stop or modify ARV regimen during the study period

        Exclusion Criteria:

          1. 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

          2. 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

          3. 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

          4. Consumption of alcohol on a daily basis

          5. Active use of illicit drugs

          6. Unable to attend follow-up appointments

          7. Allergy to any salicylic acid-containing medication or salsalate

          8. AST or ALT > 2 upper limit of normal (ULN) within 6 months prior to study entry