HIV Infections, Pneumonia, Pneumocystis Carinii
Conditions
Keywords
Pneumonia, Pneumocystis carinii, Acquired Immunodeficiency Syndrome, Methylprednisolone
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.
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.
Interventions
DRUGMethylprednisolone
Sponsors
Upjohn
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
28 Days to 2 Years
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed