Telmisartan to Reduce AIDS-Related Fibrotic and Inflammatory Contributors (TRAFIC Study)

Exclusion Criteria

• •More than one HIV-1 RNA \>200 copies/mL in the 48 weeks prior to Step 1 entry.
• •One HIV-1 RNA 200-500 copies/mL in the 24 weeks prior to Step 1 entry that is not immediately preceded and followed by HIV-1 RNA \<50 copies/mL.
• •NOTE: The preceding viral load \<50 copies/mL may be \>24 weeks prior to Step 1 entry.
• •Confirmed systolic blood pressure \>160 mmHg or \<100 mmHg or diastolic blood pressure \>100 mmHg.
• •Known untreated renal artery stenosis.
• •Known cirrhosis or severe liver disease (eg, ascites, encephalopathy, history of variceal bleeding).
• •NOTE: Potential subjects with chronic hepatitis B or C virus infection with no known cirrhosis or severe liver disease may participate in the study, provided there are no plans to start therapy for hepatitis C infection during the 48-week study duration.
• •Unstable coronary artery disease/angina or decompensated congestive heart failure.
• •Either breastfeeding or pregnant within 24 weeks prior to Step 1 entry.
• •Use of thiazolidinediones or any angiotensin receptor blocker (ARB) or angiotensin converting enzyme inhibitor (ACEi) in the 24 weeks prior to Step 1 entry. If the subject took either of these classes of medications for less than 2 weeks in the 24 weeks prior to Step 1 entry, the subject may enroll if 30 days have passed since the last dose. If the subject is diabetic and/or has a calculated glomerular filtration rate (GFR) \<60mL/min, aliskiren-containing medications are also prohibited.
• •History of intolerance, other than cough, to any ARB or ACEi.
• •Use of anticoagulants other than aspirin 81 mg or 325 mg daily. NOTE: If the subject is on aspirin 81 mg or 325 mg daily and is willing/able to stop therapy for 7 days prior to the biopsy procedures, the subject may enroll.
• •Any known bleeding disorder or coagulopathy.
• •Projected need for daily potassium supplementation for ≥2 weeks during the study period.
• •The following laboratory values obtained within 30 days prior to Step 1 entry by any US laboratory that has a CLIA certification or its equivalent:
• •* Absolute neutrophil count (ANC) ≤750 cells/mm\^3
• •* Hemoglobin ≤10 g/dL
• •* Platelet count ≤75,000/mm\^3
• •* Calculated creatinine clearance (CrCl) \<50 mL/min, as estimated by the Cockcroft-Gault equation
• •* Aspartate aminotransferase (AST) (SGOT) \>/=3x ULN (upper limit of normal)
• •* Alanine aminotransferase (ALT) (SGPT) \>/=3x ULN
• •* Partial thromboplastin time (PTT) \>1.2x ULN
• •* Prothrombin time (PT) \>1.2x ULN
• •Heritable connective tissue disorders (eg Ehlers-Danlos syndrome, osteogenesis imperfecta, Stickler syndrome, Marfan's syndrome).
• •NOTE: Subjects with acquired/autoimmune chronic inflammatory diseases/connective tissue disorders who are clinically stable (in the opinion of the site investigator) and not on a prohibited medication may enroll with approval of the A5317 study chairs.
• •Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to Step 1 entry.
• •Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
• •Any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study.
• •\- Any AE associated with the Step 1 entry biopsy that would exclude the subject from undergoing follow-up biopsy at week 48.