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

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.

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.

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.