WithdrawnPhase 3

The Safety and Effectiveness of Methylprednisolone in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Children With AIDS

United States0

Plain-language 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.

Who can participate

Age range28 Days – 2 Years

SexALL

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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.

Trial details

NCT IDNCT00000741

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

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