Optimal Treatment for Kidney Disease in HIV Infected Adults
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
1 other identifier
interventional
N/A
1 country
10
Brief 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.
Trial Health
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10 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2004
CompletedFirst Posted
Study publicly available on registry
August 6, 2004
CompletedMarch 9, 2015
August 1, 2009
August 5, 2004
March 5, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
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
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
Related Publications (4)
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.
PMID: 12704580BACKGROUNDKimmel 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.
PMID: 12899589BACKGROUNDMarras 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.
PMID: 11984599BACKGROUNDWei 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.
PMID: 12969167BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lynda Anne Szczech, MD, MSCE
Division of Nephrology, Department of Medicine, Duke University Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
August 5, 2004
First Posted
August 6, 2004
Last Updated
March 9, 2015
Record last verified: 2009-08