Optimal Treatment for Kidney Disease in HIV Infected Adults

March 5, 2015 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Wishard Hospital
      • Indianapolis, Indiana, United States, 46202-5250
        • Indiana University Hospital
      • Indianapolis, Indiana, United States, 46202-5250
        • Methodist Hospital of Indiana
    • Missouri
      • St. Louis, Missouri, United States, 63108-2138
        • Washington University (St. Louis)
    • New York
      • New York, New York, United States, 10016-6481
        • NYU/Bellevue
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44109-1998
        • MetroHealth Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hospital
      • Providence, Rhode Island, United States, 02906
        • Rhode Island Hospital
      • Providence, Rhode Island, United States, 02906
        • Stanley Street Treatment and Resource

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Lynda Anne Szczech, MD, MSCE, Division of Nephrology, Department of Medicine, Duke University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 5, 2004

First Submitted That Met QC Criteria

August 5, 2004

First Posted (Estimate)

August 6, 2004

Study Record Updates

Last Update Posted (Estimate)

March 9, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG A5179

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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