Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089518
Status:
WITHDRAWN
Last Update Posted:
2015-03-09
First Post:
2004-08-05
Brief Title:
Optimal Treatment for Kidney Disease in HIV Infected Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None