Optimal Treatment for Kidney Disease in HIV Infected Adults

Exclusion Criteria

• •Current treatment with hemodialysis or peritoneal dialysis
• •History of kidney transplant
• •Condition other than HIVAN contributing to decreased kidney function
• •ALT or AST greater than 5 times the upper limit of normal (ULN) within 28 days of study entry
• •Total bilirubin greater than 2.5 times ULN within 28 days of study entry. Patients with total bilirubin between 2.5 times and 5 times ULN who are receiving indinavir or atazanavir and do not have cirrhosis or severe liver disease are not excluded.
• •Current heart indication for an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)
• •Use of an ACEI or ARB within 7 days prior to first creatinine clearance measurement obtained for screening or any time between screening and study entry
• •Systemic steroid therapy above a replacement level within 28 days of study entry, or possible need for ongoing systemic steroid therapy above replacement level during the study
• •Current use of cimetidine
• •Use of investigational agents, except when approved by the protocol chairs
• •Allergy or sensitivity to valsartan or its formulations
• •Blood pressure not measurable by the technique described in the protocol
• •Orthostatic drop in systolic BP of 30 mm Hg or more within 24 hours prior to study entry
• •Drug or alcohol use that, in the opinion of the investigator, would interfere with the study
• •Decreased mental capacity that, in the opinion of the investigator, would interfere with the study
• •AIDS-defining opportunistic infection (OI) within 28 days prior to study entry. Patients who are receiving maintenance therapy for OIs and have no evidence of active disease are not excluded.
• •Diabetes mellitus for 2 years or longer prior to study entry. Onset of diabetes is defined as the point at which patients began oral hypoglycemics or insulin.
• •Pregnancy or breastfeeding