Back to resultsThe Safety and Effectiveness of Methylprednisolone in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Children With AIDS
Primary Purpose
Pneumonia, Pneumocystis Carinii, HIV Infections
Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Methylprednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia, Pneumocystis Carinii focused on measuring Pneumonia, Pneumocystis carinii, Acquired Immunodeficiency Syndrome, Methylprednisolone
Eligibility 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.
Sites / Locations
- UCSD Med Ctr / Pediatrics / Clinical Sciences
- Chicago Children's Memorial Hosp
- St Louis Univ School of Medicine
- Bellevue Hosp / New York Univ Med Ctr
- Columbia Presbyterian Med Ctr
- Duke Univ Med Ctr
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000741
First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Upjohn
1. Study Identification
Unique Protocol Identification Number
NCT00000741
Brief Title
The Safety and Effectiveness of Methylprednisolone in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Children With AIDS
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Upjohn
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumocystis Carinii, HIV Infections
Keywords
Pneumonia, Pneumocystis carinii, Acquired Immunodeficiency Syndrome, Methylprednisolone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Days
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dankner WM
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bozzette S
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Spector SA
Official's Role
Study Chair
Facility Information:
Facility Name
UCSD Med Ctr / Pediatrics / Clinical Sciences
City
La Jolla
State/Province
California
ZIP/Postal Code
920930672
Country
United States
Facility Name
Chicago Children's Memorial Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606143394
Country
United States
Facility Name
St Louis Univ School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Bellevue Hosp / New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia Presbyterian Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
277103499
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
2136587
Citation
National Institutes of Health-University of California Expert Panel for Corticosteroids as Adjunctive Therapy for Pneumocystis Pneumonia. Consensus statement on the use of corticosteroids as adjunctive therapy for pneumocystis pneumonia in the acquired immunodeficiency syndrome. N Engl J Med. 1990 Nov 22;323(21):1500-4. doi: 10.1056/NEJM199011223232131. No abstract available.
Results Reference
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Learn more about this trial
The Safety and Effectiveness of Methylprednisolone in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Children With AIDS
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