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
Sponsor study identifier
interventional
0
1 country
10
Study Start
Not reported
Date not reportedPrimary Completion
Not reported
Date not reportedStudy Completion
Not reported
Date not reportedThe 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 5, 2004
Actual (reported)August 6, 2004
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Indiana University Hospital
Indianapolis, Indiana, 46202-5250, United States
Methodist Hospital of Indiana
Indianapolis, Indiana, 46202-5250, United States
Wishard Hospital
Indianapolis, Indiana, 46202, United States
Washington University (St. Louis)
St Louis, Missouri, 63108-2138, United States
NYU/Bellevue
New York, New York, 10016-6481, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109-1998, United States
Herman ES, Klotman PE. HIV-associated nephropathy: Epidemiology, pathogenesis, and treatment. Semin Nephrol. 2003 Mar;23(2):200-8. doi: 10.1053/snep.2003.50018.
Kimmel PL, Barisoni L, Kopp JB. Pathogenesis and treatment of HIV-associated renal diseases: lessons from clinical and animal studies, molecular pathologic correlations, and genetic investigations. Ann Intern Med. 2003 Aug 5;139(3):214-26.
Lynda Anne Szczech, MD, MSCE
Division of Nephrology, Department of Medicine, Duke University Medical Center
0 participants (actual enrollment reported by the registry).
First Submitted
August 5, 2004
First Posted
August 6, 2004
Last Updated
March 9, 2015
Record last verified: 2009-08
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Source: ClinicalTrials.gov.
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Rhode Island Hospital
Providence, Rhode Island, 02906, United States
Stanley Street Treatment and Resource
Providence, Rhode Island, 02906, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
Marras D, Bruggeman LA, Gao F, Tanji N, Mansukhani MM, Cara A, Ross MD, Gusella GL, Benson G, D'Agati VD, Hahn BH, Klotman ME, Klotman PE. Replication and compartmentalization of HIV-1 in kidney epithelium of patients with HIV-associated nephropathy. Nat Med. 2002 May;8(5):522-6. doi: 10.1038/nm0502-522.
Wei A, Burns GC, Williams BA, Mohammed NB, Visintainer P, Sivak SL. Long-term renal survival in HIV-associated nephropathy with angiotensin-converting enzyme inhibition. Kidney Int. 2003 Oct;64(4):1462-71. doi: 10.1046/j.1523-1755.2003.00230.x.