![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
---|---|
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00089518 |
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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections Kidney Disease |
Drug: Valsartan |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 64 |
Study Completion Date: | August 2006 |
ART for the treatment of HIV may slow the progression of HIV-associated nephropathy (HIVAN) to end-stage renal disease (ESRD); nevertheless, it is predicted that many HIV infected patients on ART will reach ESRD by the next decade. Medications that affect the renin-angiotensin system, such as the ARB valsartan, may be useful in treating HIVAN. In a small study of HIV infected patients with HIVAN treated with the angiotensin-converting enzyme inhibitor (ACEI) fosinopril, kidney function was stable in patients who took the ACEI, but function decreased in patients who did not. These data are promising, and suggest that an ARB like valsartan may also slow the progression of HIVAN and improve patients' prognosis. This study will compare valsartan and ART to ART alone in slowing kidney disease progression in people with HIV.
This study will last 96 weeks. All participants will continue taking their current ART regimen during the study and will be randomly assigned to one of two arms: Arm 1 will receive valsartan daily, while Arm 2 will receive placebo daily. Doses of drug or placebo may be adjusted during the first 8 weeks based on blood pressure readings taken during the study. In addition, if patients are on other antihypertensive drugs, dosage adjustments may be necessary for those drugs during the study. No ART or antihypertensive drugs other than valsartan will be provided by the study. Study visits will occur every week until Week 8, then every 8 weeks until the end of the study at Week 96. Study visits will include physical examination, medication assessment, and blood pressure readings. In addition, blood collection will occur at entry, Weeks 2, 4, 6, and 8, and every 8 weeks thereafter.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Indiana | |
Indiana University Hospital | |
Indianapolis, Indiana, United States, 46202-5250 | |
Methodist Hospital of Indiana | |
Indianapolis, Indiana, United States, 46202-5250 | |
Wishard Hospital | |
Indianapolis, Indiana, United States, 46202 | |
United States, Missouri | |
Washington University (St. Louis) | |
St. Louis, Missouri, United States, 63108-2138 | |
United States, New York | |
NYU/Bellevue | |
New York, New York, United States, 10016-6481 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
MetroHealth Medical Center | |
Cleveland, Ohio, United States, 44109-1998 | |
United States, Rhode Island | |
The Miriam Hospital | |
Providence, Rhode Island, United States, 02906 | |
Rhode Island Hospital | |
Providence, Rhode Island, United States, 02906 | |
Stanley Street Treatment and Resource | |
Providence, Rhode Island, United States, 02906 |
Study Chair: | Lynda Anne Szczech, MD, MSCE | Division of Nephrology, Department of Medicine, Duke University Medical Center |
Study ID Numbers: | ACTG A5179 |
Study First Received: | August 5, 2004 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00089518 |
Health Authority: | United States: Food and Drug Administration |
Treatment Experienced |
Virus Diseases AIDS-Associated Nephropathy Sexually Transmitted Diseases, Viral Urologic Diseases HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Kidney Diseases Retroviridae Infections Valsartan Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Therapeutic Uses Lentivirus Infections |
Cardiovascular Agents Antihypertensive Agents Infection Pharmacologic Actions |