The Safety and Effectiveness of Methylprednisolone in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Children With AIDS
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
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 Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
-
Recombinant erythropoietin and any FDA-approved cytokine for management of anemia.
-
Antiretroviral agents.
Patients must have:
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Documented HIV infection.
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PCP.
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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
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
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 | Saint Louis | Missouri | United States | 63104 |
4 | Bellevue Hosp / New York Univ Med Ctr | New York | New York | United States | 10016 |
5 | Columbia Presbyterian Med Ctr | New York | New York | United States | 10032 |
6 | 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,
Study Documents (Full-Text)
None provided.More Information
Publications
- ACTG 170