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

Phase 3

Withdrawn

• Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

• Registration Number: NCT00000741
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Timeline

• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (6)

Columbia Presbyterian Med Ctr; 🇺🇸 New York, New York, United States

Bellevue Hosp / New York Univ Med Ctr; 🇺🇸 New York, New York, United States

Duke Univ Med Ctr; 🇺🇸 Durham, North Carolina, United States

St Louis Univ School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

UCSD Med Ctr / Pediatrics / Clinical Sciences; 🇺🇸 La Jolla, California, United States

Chicago Children's Memorial Hosp; 🇺🇸 Chicago, Illinois, United States