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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.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsor: Upjohn
Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000819
  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 II

Study Type: Interventional
Study Design: 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000819

Locations
United States, California
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Harbor UCLA Med Ctr
Torrance, California, United States, 90502
United States, Indiana
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
United States, New York
SUNY / State Univ of New York
Syracuse, New York, United States, 13210
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, United States, 10468
Beth Israel Med Ctr
New York, New York, United States, 10003
Adirondack Med Ctr at Saranac Lake
Albany, New York, United States, 122083479
Mid - Hudson Care Ctr
Albany, New York, United States, 122083479
Albany Med College / Division of HIV Medicine A158
Albany, New York, United States, 122083479
Harlem Hosp Ctr
New York, New York, United States, 10037
United States, Ohio
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
MetroHealth Med Ctr
Cleveland, Ohio, United States, 441091998
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

Study ID Numbers: ACTG 271
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00000819     History of Changes
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:
Anti-Inflammatory Agents
Prednisone
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Infection
Hormones
Urologic Diseases
Therapeutic Uses
Kidney Diseases
Retroviridae Infections
AIDS-Associated Nephropathy
RNA Virus Infections
Immune System Diseases
Antineoplastic Agents, Hormonal
Acquired Immunodeficiency Syndrome
Glucocorticoids
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 25, 2009