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

This study has been withdrawn prior to enrollment.
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID) Identifier:
First received: November 2, 1999
Last updated: October 24, 2012
Last verified: October 2012
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.

Condition Intervention Phase
Pneumonia, Pneumocystis Carinii
HIV Infections
Drug: Methylprednisolone
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Controlled Randomized Trial to Study the Efficacy of Adjunctive Methylprednisolone for the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Pediatric AIDS Patients

Resource links provided by NLM:

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Enrollment: 0
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.

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria

Concurrent Medication:


  • 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:


  • 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00000741

United States, California
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
United States, Illinois
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
United States, Missouri
St Louis Univ School of Medicine
St Louis, Missouri, United States, 63104
United States, New York
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
United States, North Carolina
Duke Univ Med Ctr
Durham, North Carolina, United States, 277103499
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Dankner WM
Study Chair: Bozzette S
Study Chair: Spector SA
  More Information

Publications: Identifier: NCT00000741     History of Changes
Other Study ID Numbers: ACTG 170 
Study First Received: November 2, 1999
Last Updated: October 24, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Pneumonia, Pneumocystis carinii
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
Pneumonia, Pneumocystis
Lung Diseases
Lung Diseases, Fungal
Pneumocystis Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Protective Agents processed this record on May 26, 2016