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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00000741
• Other study ID #: ACTG 170
• Status: Withdrawn
• Phase: Phase 3

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Pneumonia
• Pneumonia, Pneumocystis
• Pneumonia, Pneumocystis Carinii

Intervention

Drug:
• Methylprednisolone

Locations

Country	Name	City	State
United States	Chicago Children's Memorial Hosp	Chicago	Illinois
United States	Duke Univ Med Ctr	Durham	North Carolina
United States	UCSD Med Ctr / Pediatrics / Clinical Sciences	La Jolla	California
United States	Bellevue Hosp / New York Univ Med Ctr	New York	New York
United States	Columbia Presbyterian Med Ctr	New York	New York
United States	St Louis Univ School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Upjohn

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation