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This study has been withdrawn prior to enrollment.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

November 2, 1999
October 24, 2012
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Complete list of historical versions of study NCT00000741 on ClinicalTrials.gov Archive Site
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The Safety and Effectiveness of Methylprednisolone in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Children With AIDS
A Controlled Randomized Trial to Study the Efficacy of Adjunctive Methylprednisolone for the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Pediatric AIDS Patients

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.

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.

Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
  • Pneumonia, Pneumocystis Carinii
  • HIV Infections
Drug: Methylprednisolone
Not Provided
Consensus statement on the use of corticosteroids as adjunctive therapy for pneumocystis pneumonia in the acquired immunodeficiency syndrome. The National Institutes of Health-University of California Expert Panel for Corticosteroids as Adjunctive Therapy for Pneumocystis Pneumonia. N Engl J Med. 1990 Nov 22;323(21):1500-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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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.
Both
up to 2 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000741
ACTG 170
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National Institute of Allergy and Infectious Diseases (NIAID)
Upjohn
Study Chair: Dankner WM
Study Chair: Bozzette S
Study Chair: Spector SA
National Institute of Allergy and Infectious Diseases (NIAID)
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP