- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000741
The Safety and Effectiveness of Methylprednisolone in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Children With AIDS
October 27, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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La Jolla, California, United States, 920930672
- UCSD Med Ctr / Pediatrics / Clinical Sciences
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Illinois
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Chicago, Illinois, United States, 606143394
- Chicago Children's Memorial Hosp
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Missouri
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Saint Louis, Missouri, United States, 63104
- St Louis Univ School of Medicine
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New York
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New York, New York, United States, 10016
- Bellevue Hosp / New York Univ Med Ctr
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New York, New York, United States, 10032
- Columbia Presbyterian Med Ctr
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North Carolina
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Durham, North Carolina, United States, 277103499
- Duke Univ Med Ctr
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 weeks to 2 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Dankner WM
- Study Chair: Bozzette S
- Study Chair: Spector SA
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Actual)
November 4, 2021
Last Update Submitted That Met QC Criteria
October 27, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Bacterial Infections and Mycoses
- Mycoses
- Lung Diseases, Fungal
- Pneumocystis Infections
- Pneumonia
- Pneumonia, Pneumocystis
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
Other Study ID Numbers
- ACTG 170
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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