Status:
WITHDRAWN
The Safety and Effectiveness of Methylprednisolone in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Children With AIDS
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Upjohn
Conditions:
Pneumonia, Pneumocystis Carinii
HIV Infections
Eligibility:
All Genders
28-2 years
Phase:
PHASE3
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 re...
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 ...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00000741
Last Update
November 4 2021
Active Locations (6)
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1
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
2
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
3
St Louis Univ School of Medicine
St Louis, Missouri, United States, 63104
4
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016