Optimal Treatment for Kidney Disease in HIV Infected Adults

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The angiotensin receptor blocker (ARB) valsartan is a drug commonly used to treat high blood pressure. Valsartan may also help slow down the progression of kidney disease in HIV infected people. The purpose of this study is to compare valsartan and antiretroviral therapy (ART) to ART alone in slowing kidney disease progression in people with HIV.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Angiotensin Receptor Antagonists; Valsartan

Criteria

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