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 on November 2, 1999. Last Updated on 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:	Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Treatment
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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Pneumonia

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-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.

ClinicalTrials.gov Identifier:	NCT00000741 History of Changes
Other Study ID Numbers:	ACTG 170
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
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:

HIV Infections
Acquired Immunodeficiency Syndrome
Pneumonia
Pneumonia, Pneumocystis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lung Diseases
Respiratory Tract Diseases

Respiratory Tract Infections
Lung Diseases, Fungal
Mycoses
Pneumocystis Infections
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents

ClinicalTrials.gov processed this record on February 09, 2012