The Safety and Effectiveness of Methylprednisolone in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Children With AIDS

This study has been terminated.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:	Upjohn
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000741

Purpose

To determine the effect of methylprednisolone on respiratory failure in HIV-infected patients with presumed or confirmed pneumocystis carinii pneumonia who are stratified for presence or absence of respiratory failure at the time of randomization to the study.

Condition	Intervention	Phase
Pneumonia, Pneumocystis Carinii HIV Infections	Drug: Methylprednisolone	Phase III

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Efficacy Study
Official Title:	A Controlled Randomized Trial to Study the Efficacy of Adjunctive Methylprednisolone for the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Pediatric AIDS Patients

Resource links provided by NLM:

MedlinePlus related topics: AIDS Pneumonia

Drug Information available for: Methylprednisolone

U.S. FDA Resources

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

Estimated Enrollment:

210

Detailed Description:

HIV-infected children are randomized to receive adjunctive therapy with intravenous methylprednisolone or placebo. Treatment is administered for 10 days. Primary antipneumocystis therapy with TMP/SMX or systemic pentamidine is selected by the individual investigator and given for 21 days. Patients are stratified at the time of randomization by the presence or absence of respiratory failure.

Eligibility

Ages Eligible for Study:	up to 2 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

Recombinant erythropoietin and any FDA-approved cytokine for management of anemia.
Antiretroviral agents.

Patients must have:

Documented HIV infection.
PCP.
No more than 36 hours of prior primary therapy for confirmed or presumed PCP.

Prior Medication:

Allowed:

Up to 35 hours of primary therapy for confirmed or presumed PCP.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

Demonstrated intolerance to steroids.
Requirement for steroids at greater than physiological doses for other medical conditions.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000741

Locations

United States, California
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
United States, Illinois
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
United States, Missouri
St Louis Univ School of Medicine
St. Louis, Missouri, United States, 63104
United States, New York
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
United States, North Carolina
Duke Univ Med Ctr
Durham, North Carolina, United States, 277103499

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Upjohn

Investigators

Study Chair:	Dankner WM
Study Chair:	Bozzette S
Study Chair:	Spector SA

More Information

Publications:

[No authors listed] Consensus statement on the use of corticosteroids as adjunctive therapy for pneumocystis pneumonia in the acquired immunodeficiency syndrome. The National Institutes of Health-University of California Expert Panel for Corticosteroids as Adjunctive Therapy for Pneumocystis Pneumonia. N Engl J Med. 1990 Nov 22;323(21):1500-4. No abstract available.

Study ID Numbers:	ACTG 170
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000741 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Pneumonia, Pneumocystis carinii
Acquired Immunodeficiency Syndrome
Methylprednisolone

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Antineoplastic Agents
Methylprednisolone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Infection
Hormones
Neuroprotective Agents
Pneumonia, Pneumocystis
Mycoses
Respiratory Tract Diseases

Respiratory Tract Infections
Therapeutic Uses
Retroviridae Infections
Lung Diseases, Fungal
Methylprednisolone Hemisuccinate
RNA Virus Infections
Antineoplastic Agents, Hormonal
Immune System Diseases
Acquired Immunodeficiency Syndrome
Gastrointestinal Agents
Methylprednisolone acetate
Glucocorticoids
Protective Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on November 30, 2009