The Safety and Effectiveness of Methylprednisolone in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Children With AIDS
A Controlled Randomized Trial to Study the Efficacy of Adjunctive Methylprednisolone for the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Pediatric AIDS Patients
1 other identifier
interventional
N/A
1 country
6
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.
Trial Health
Trial Health Score
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6 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 4, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394, United States
St Louis Univ School of Medicine
St Louis, Missouri, 63104, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Columbia Presbyterian Med Ctr
New York, New York, 10032, United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499, United States
Related Publications (1)
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.
PMID: 2136587BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dankner WM
- STUDY CHAIR
Bozzette S
- STUDY CHAIR
Spector SA
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
November 4, 2021
Record last verified: 2021-10