Status:
TERMINATED
DB289 Versus TMP-SMX for the Treatment of Acute Pneumocystis Jiroveci Pneumonia (PCP)
Lead Sponsor:
Immtech Pharmaceuticals, Inc
Conditions:
Pneumonia, Interstitial Plasma Cell
Pneumocystis Carinii Pneumonia
Eligibility:
All Genders
13-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate the non-inferiority of pafuramidine maleate (DB289)versus trimethoprim-sulfamethoxazole (TMP-SMX)for the treatment of mild to moderately severe Pneumocystis...
Detailed Description
The gold standard treatment for PCP is trimethoprim-sulfamethoxazole (TMP-SMX). This drug is highly effective; however, a significant number of patients are unable to complete a course of therapy due ...
Eligibility Criteria
Inclusion
- Documented or presumptive HIV infection
- Signs and symptoms of PCP present for at least 5 days
- Pneumocystis jiroveci confirmed in BAL fluid or induced sputum sample
- Suitable candidate for oral therapy
- Alveolar-arterial oxygen (A-a) gradient \< or = 45 mm Hg on room air and partial pressure of oxygen (pO2) \> or = 60 mm Hg
- No more than 48 hours of prior treatment in the preceding 7 days for PCP treatment at full doses; failure of Pneumocystis prophylaxis or use of medications recommended for treatment of PCP at doses less than recommended by the CDC Guidelines is acceptable.
Exclusion
- Unwilling or unable to discontinue use of other medications with anti-PCP activity
- AIDS related cachexia (weight loss that is more than 10% of ideal body weight)
- Severe diarrhea and/or vomiting
- History of hypersensitivity or severe or life threatening toxicity to TMP-SMX, other sulfonamides or pentamidine
- Active illicit drug use
- Impending respiratory failure or need for intubation
- AST and ALT levels \> 3 times the upper limit of normal
- History of pancreatitis
- Severe PCP
- Karnofsky score \< or = 20
- Terminal HIV disease or life expectancy of less than 6 months
- Acute concurrent pulmonary pathological condition that would obscure the evaluation of response to therapy
- Concomitant use of amphotericin B, gangciclovir, cyclosporine, warfarin, thiazide diuretics, phenytoin, methotrexate, leucovorin
- Receipt of systemic corticosteroids (except replacement therapy) within 14 days of study entry at high doses for 3 or more consecutive days. Concomitant use of corticosteroids, other than replacement doses for adrenal insufficiency, is also excluded unless the patient meets the CDC criteria for use of corticosteroids for treatment of PCP
- Pregnant or lactating women
- The subject has been previously enrolled in the study
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00302341
Start Date
May 1 2006
End Date
December 1 2008
Last Update
March 7 2013
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California
San Francisco, California, United States, 94110
2
The University of Chicago
Chicago, Illinois, United States, 60637
3
Henry Ford Health System
Detroit, Michigan, United States, 48202
4
NYU School of Medicine
New York, New York, United States, 10016