DB289 Versus TMP-SMX for the Treatment of Acute Pneumocystis Jiroveci Pneumonia (PCP)

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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 pneumonia (PCP).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Immtech Pharmaceuticals, Inc
• Treatments: Maleic acid; Pafuramidine; Sulfamethoxazole; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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