A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN)

This study has been completed.
Sponsor:
Collaborator:
Upjohn
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000819
First received: November 2, 1999
Last updated: April 13, 2012
Last verified: April 2012
  Purpose

To determine the efficacy and safety of prednisone in patients with HIV-associated nephropathy. To determine the effects of prednisone on serum creatinine, urinary protein, and creatinine clearance.

HIV-associated nephropathy is characterized by heavy proteinuria, rapidly progressive renal insufficiency, and distinct nephropathologic changes. The syndrome most often occurs in patients with advanced HIV disease. Little is known about the effects of corticosteroids on the progression of HIV disease. In light of the possible beneficial effects of corticosteroids on HIV-associated nephropathy, a controlled trial using prednisone is warranted.


Condition Intervention Phase
HIV Infections
AIDS-Associated Nephropathy
Drug: Prednisone
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 54
Study Completion Date: September 1996
Detailed Description:

HIV-associated nephropathy is characterized by heavy proteinuria, rapidly progressive renal insufficiency, and distinct nephropathologic changes. The syndrome most often occurs in patients with advanced HIV disease. Little is known about the effects of corticosteroids on the progression of HIV disease. In light of the possible beneficial effects of corticosteroids on HIV-associated nephropathy, a controlled trial using prednisone is warranted.

Patients are randomized to receive prednisone or placebo for 11 weeks, followed by 13 weeks of observation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients must have:

  • HIV infection.
  • Biopsy-confirmed glomerulosclerosis and/or mesangial proliferation within 90 days prior to study entry.
  • Mild to severe renal insufficiency that is stable or worsening.
  • No AIDS-defining opportunistic infections or malignancies.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Poorly controlled hypertension or diabetes mellitus.
  • Peptic ulcer disease with gastrointestinal bleeding.
  • Active symptomatic bacterial, protozoal, fungal, or viral infections (other than HIV disease).
  • Superimposed renal disease that is due to processes other than focal glomerulosclerosis or mesangial proliferation, including but not limited to obstructive uropathy, acute tubular necrosis, and prerenal azotemia.
  • Emotional problems sufficient to prevent adequate compliance with study therapy.

Concurrent Medication:

Excluded:

  • IV amphotericin B.
  • IV aminoglycosides.
  • IV foscarnet.
  • IV pentamidine.
  • Trimethoprim > 200 mg/day.
  • Nonsteroidal anti-inflammatory agents.
  • Angiotensin converting enzyme inhibitors (benzapril, captopril, enalapril, fosinopril, lisinopril, guinapril, and ramipril) except for refractory hypertension.

Concurrent Treatment:

Excluded:

  • Iodinated radiocontrast dye.

Patients with the following prior conditions are excluded:

  • Active pulmonary disease on chest radiograph within 60 days prior to study entry.
  • CMV retinitis on ophthalmologic evaluation within 60 days prior to study entry.
  • Positive blood culture for mycobacteria 10-60 days prior to study entry.

Prior Medication:

Excluded:

  • Prior corticosteroid therapy for HIVAN.
  • Corticosteroid therapy for any indication within 30 days prior to study entry.
  • Continuous nonsteroidal anti-inflammatory agents for more than 15 days during the 4 weeks prior to study entry.

Prior Treatment:

Excluded within 30 days prior to study entry:

  • Dialysis for acute or chronic renal failure.
  • Iodinated radiocontrast dye.

Required:

  • Stable antiretroviral therapy with AZT alone or in combination with ddI, ddC, or d4T for at least 4 weeks unless contraindicated.
  • PCP prophylaxis with TMP/SMX, pentamidine aerosol, dapsone, or atovaquone.
  • MAC prophylaxis with rifabutin or clarithromycin for patients with CD4 count < 100 cells/mm3.
  • Mycobacterium tuberculosis prophylaxis with isoniazid or another accepted regimen for patients with a positive or previously positive tuberculin test and for anergic patients who are known household or close contacts of infectious TB patients or who are from groups in which the prevalence of TB is 10 percent or higher.
  • Investigational drugs unless exempted by protocol chair.
  • Other medications unless expressly prohibited.

Active alcohol or drug abuse.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000819

Locations
United States, California
UCLA CARE Center CRS
Los Angeles, California, United States, 90095
Ucsf Aids Crs
San Francisco, California, United States
Harbor-UCLA Med. Ctr. CRS
Torrance, California, United States, 90502
United States, Indiana
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States, 21287
United States, New York
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, United States, 10003
United States, Ohio
Case CRS
Cleveland, Ohio, United States, 44106
MetroHealth CRS
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
Upjohn
Investigators
Study Chair: Kalayjian R
Study Chair: Smith MC
Study Chair: Lederman M
  More Information

Publications:
Kalayjian R, Phinney M, Austen J, Gripshover B, Carey J, Rahman M, Weigel K, Smith MC. Prednisone improves renal function in HIV-associated nephropathy (HIVAN). Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:154

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000819     History of Changes
Other Study ID Numbers: ACTG 271, 11247
Study First Received: November 2, 1999
Last Updated: April 13, 2012
Health Authority: Unspecified

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
AIDS-Related Complex
Prednisone
AIDS-Associated Nephropathy

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Kidney Diseases
AIDS-Associated Nephropathy
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Urologic Diseases
Prednisone
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 20, 2014