A Phase III, Randomized, Placebo-Controlled, Double-Blind Trial of an Angiotensin Receptor Blocker (Valsartan) and Highly Active Antiretroviral Therapy (HAART) Versus HAART Alone for the Treatment of HIV-Associated Nephropathy

Inclusion Criteria: * 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