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This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Upjohn
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000741
First received: November 2, 1999
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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.

  Eligibility

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000741

Locations
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
Upjohn
Investigators
Study Chair: Dankner WM
Study Chair: Bozzette S
Study Chair: Spector SA
  More Information

Publications:
ClinicalTrials.gov 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
Methylprednisolone

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Pneumonia
Pneumonia, Pneumocystis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Fungal
Mycoses
Pneumocystis Infections
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics

ClinicalTrials.gov processed this record on September 22, 2014