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

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00000741 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Controlled Randomized Trial to Study the Efficacy of Adjunctive Methylprednisolone for the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Pediatric AIDS Patients

Brief Summary

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.

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Pneumonia, Pneumocystis Carinii
HIV Infections

Intervention ^ICMJE

Drug: Methylprednisolone

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

210

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

up to 2 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00000741

Responsible Party

Study ID Numbers ^ICMJE

ACTG 170

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Upjohn

Investigators ^ICMJE

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

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

September 1992

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP