Clinical trial NCT00000741: The Safety and Effectiveness of Methylprednisolone in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Children With AIDS
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Pneumonia, Pneumocystis Carinii
HIV Infections
Keywords: Pneumonia, Pneumocystis carinii
Acquired Immunodeficiency Syndrome
Methylprednisolone
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Upjohn
First posted: 2001-08-31
Enrollment: 0
Sex: ALL
Minimum age (years): 28
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Med Ctr / Pediatrics / Clinical Sciences
state: California
city: Chicago
country: United States
facility: Chicago Children's Memorial Hosp
state: Illinois
city: Saint Louis
country: United States
facility: St Louis Univ School of Medicine
state: Missouri
city: New York
country: United States
facility: Bellevue Hosp / New York Univ Med Ctr
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Med Ctr
state: New York
city: Durham
country: United States
facility: Duke Univ Med Ctr
state: North Carolina
Study officials:
name: Dankner WM
role: STUDY_CHAIR
name: Bozzette S
role: STUDY_CHAIR
name: Spector SA
role: STUDY_CHAIR
References:
citation: 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.