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

NCT ID: NCT00000741

Last Updated: 2021-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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Pneumonia, Pneumocystis Carinii HIV Infections

Keywords

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Pneumonia, Pneumocystis carinii Acquired Immunodeficiency Syndrome Methylprednisolone

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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Methylprednisolone

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

28 Days

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Upjohn

INDUSTRY

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Principal Investigators

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Dankner WM

Role: STUDY_CHAIR

Bozzette S

Role: STUDY_CHAIR

Spector SA

Role: STUDY_CHAIR

Locations

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UCSD Med Ctr / Pediatrics / Clinical Sciences

La Jolla, California, United States

Site Status

Chicago Children's Memorial Hosp

Chicago, Illinois, United States

Site Status

St Louis Univ School of Medicine

St Louis, Missouri, United States

Site Status

Bellevue Hosp / New York Univ Med Ctr

New York, New York, United States

Site Status

Columbia Presbyterian Med Ctr

New York, New York, United States

Site Status

Duke Univ Med Ctr

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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National Institutes of Health-University of California Expert Panel for Corticosteroids as Adjunctive Therapy for Pneumocystis Pneumonia. Consensus statement on the use of corticosteroids as adjunctive therapy for pneumocystis pneumonia in the acquired immunodeficiency syndrome. N Engl J Med. 1990 Nov 22;323(21):1500-4. doi: 10.1056/NEJM199011223232131. No abstract available.

Reference Type BACKGROUND
PMID: 2136587 (View on PubMed)

Other Identifiers

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ACTG 170

Identifier Type: -

Identifier Source: org_study_id