View Clinical Trial (Medical Research Study)

Randomized, Non-Blinded Clinical Trial Examining the Effects of Oral Corticosteroids Therapy on the Development of Interstitial Fibrosis in Patients With HIV Infection and Pneumocystis Jirovecii Pneumonia (PCP) and pO2 of >70 at Presentation.

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Conditions:		Pneumocystis Carinii Pneumonia
Purpose:		To explore the effects of corticosteroid therapy on pulmonary fibrosis and potentially pneumothorax in patients with mild PCP (pO2 >70mmHg) combined with the standard of care treatment of antibiotic therapy.
Study Summary:		Although the development of highly active anti-retroviral therapy has substantially reduced the incidence of Pneumocystis jirovecii pneumonia (PCP) among HIV-infected individuals, PCP remains one of the most common presenting opportunistic infection among this population. The use of adjunctive corticosteroids in the treatment of patients with moderate to severe PCP has resulted in a significant improvement in the development of respiratory failure and mortality. Past studies have demonstrated no clinical benefit in patients with mild disease (pO2>75 torr on room air). This may have been due to the fact that few patients with mild disease develop either respiratory failure or die during the course of the acute illness so that a statistical difference could not be demonstrated. However, considering parameters other than mortality, there is some evidence to suggest that patients with high pO2 concentrations benefit from adjunctive corticosteroids. PCP is associated with the development of pulmonary fibrosis and this can have significant consequences. Pathological studies have shown the development of interstitial fibrosis late in the course of acute illness. Studies have documented the presence of diffuse interstitial pneumonitis five months after the onset of acute illness. Therefore, patients with PCP infection, regardless of their pO2 level on presentation may benefit from corticosteroid therapy. The current standard of care therapy for patients with PCP does not involve the addition of corticosteroids to standard antibiotics in those patients with pO2>70 mmHG. This study propose to conduct a randomized, prospective, un-blinded clinical trial to explore the effects of corticosteroid therapy on pulmonary fibrosis in patients with mild PCP who are admitted to the George Washington University Hospital.
Criteria:		Inclusion Criteria: - HIV Infection, - Hospital admission for suspected PCP, - Confirmatory test for PCP (bronchoscopy with bronchoalveolar lavage), pO2>70 mmHg or pO2<70 mmHg while breathing room air, - 18 years or older Exclusion Criteria: - Contraindications to corticosteroid therapy, - Unable and or unwilling to perform PFTS or to return for follow-up evaluations, - Underlying lung disease such as emphysema, untreated active tuberculosis, Uncontrolled diabetes (fasting glucose > 250 mg/dL, - Uncontrolled hypertension (160/95 mmHg), - Pregnancy
NCT ID:		NCT00636935
Primary Contact:		Principal Investigator Afsoon Roberts, M.D. George Washington University Medical Faculty Associates Beverly D. Bentley, M.P.H. Phone: 202-741-3399 Email: bbentley@gwu.mfa.edu
Backup Contact:		N/A
Location Contact:		Washington, District of Columbia 20037 United States There is no listed contact information for this specific location. Site Status: Recruiting

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