Optimal Treatment for Kidney Disease in HIV Infected Adults

• HIV infected
• Evidence of HIV-associated nephropathy by kidney biopsy performed locally within 24 weeks prior to study entry
• On ART for at least 42 days prior to study entry and willing to continue ART while on study
• Systolic blood pressure (BP) between 91 mm Hg and 170 mm Hg and diastolic BP 105 mm Hg or less within 24 hours of study entry
• Stable kidney function, as indicated by two consecutive calculated creatinine clearance measurements higher than 30 ml/min
• Serum potassium of less than Grade 1 within 7 days prior to study entry
• Willing to follow dose adjustments of non-study antihypertensive drugs if necessary
• Willing to use acceptable forms of contraception

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