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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Upjohn |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000741 |
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 |
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Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Methylprednisolone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 210 |
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:
Allowed:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
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 |
Study Chair: | Dankner WM | |
Study Chair: | Bozzette S | |
Study Chair: | Spector SA |
Study ID Numbers: | ACTG 170 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000741 |
Health Authority: | United States: Federal Government |
Pneumonia, Pneumocystis carinii Acquired Immunodeficiency Syndrome Methylprednisolone |
Sexually Transmitted Diseases, Viral Methylprednisolone Pneumocystosis Acquired Immunodeficiency Syndrome Methylprednisolone acetate Prednisolone acetate Immunologic Deficiency Syndromes Virus Diseases Mycoses Pneumonia, Pneumocystis Pneumocystis Infections |
Respiratory Tract Diseases Respiratory Tract Infections HIV Infections Lung Diseases Prednisolone Sexually Transmitted Diseases Retroviridae Infections Pneumonia Methylprednisolone Hemisuccinate Lung Diseases, Fungal |
Anti-Inflammatory Agents RNA Virus Infections Slow Virus Diseases Antineoplastic Agents, Hormonal Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics Infection |
Hormones Glucocorticoids Protective Agents Neuroprotective Agents Pharmacologic Actions Autonomic Agents Therapeutic Uses Lentivirus Infections Peripheral Nervous System Agents Central Nervous System Agents |