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

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Withdrawn; Phase 3

Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

Treatments: Drug: Methylprednisolone

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00000741

ACTG 170

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 28 days to 2 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.