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| 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) |
| Estimated Enrollment: | 54 |
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 |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded within 30 days prior to study entry:
Required:
Active alcohol or drug abuse.
Contacts and 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 | |
| Study Chair: | Kalayjian R | |
| Study Chair: | Smith MC | |
| Study Chair: | Lederman M |
More Information
| 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 |
|
AIDS-Related Complex Prednisone AIDS-Associated Nephropathy |
|
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 |