Randomized Phase I Study of Trimetrexate Glucuronate (TMTX) With Leucovorin (LCV) Protection Plus Dapsone Versus Trimethoprim / Sulfamethoxazole (TMP/SMX) for Treatment of Moderately Severe Episodes of Pneumocystis Carinii Pneumonia

Launched by U.S. BIOSCIENCE · Aug 30, 2001

Keywords

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Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Empiric therapy for other opportunistic pulmonary infection (TB or fungi) for the first 72 hours of study enrollment ONLY, until presence of suspected pathogens can be confidently excluded.
• Patients must have:
• • AIDS.
• • Confirmed diagnosis of PCP.
• • Alveolar-arterial differences in dissolved oxygen \>= 35 mm Hg but \< 55 mm Hg on room air.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Severe renal or hepatic dysfunction.
• • Serious or life-threatening intolerance to TMP/SMX, TMTX, or dapsone.
• • Concurrent pneumothorax.
• * Active pulmonary tuberculosis or other inadequately treated opportunistic pulmonary infection (e.g., Cryptococcus neoforms, CMV). NOTE:
• • Identification of Mycobacterium avium or CMV in sputum or BAL fluid does not exclude, since these organisms may be present without causing disease.
• • Pulmonary Kaposi's sarcoma.
• • Active opportunistic infections or malignancies requiring induction therapy with bone marrow suppressive drugs (e.g., ganciclovir) or hepatotoxic drugs (e.g., chemotherapy).
• • Unable to have arterial blood gases on room air obtained at baseline.
• • Unwilling to undergo bronchoscopy, if sputum induction does not reveal Pneumocystis carinii.
• • Suspected malabsorption (e.g., ileus or severe diarrhea with \> 6 stools/day).
• • Known absence of G6PD activity.
• • Large volume (1.0 to 1.5 liters) of intravenous fluid (5 percent in water) per 24 hours is medically inadvisable.
• • Unwilling to comply with study design.
• Concurrent Medication:
• Excluded:
• • Induction therapy with bone marrow suppressive drugs (e.g., ganciclovir) or hepatotoxic drugs (e.g., chemotherapy).
• • AZT, ddI, ddC, d4T, or other antiretroviral therapy.
• Patients with the following prior condition are excluded:
• Prior history of serious or life-threatening intolerance to TMP/SMX. (NOTE:
• • Patients with less severe reactions may be included at the discretion of the investigator and primary care provider.)
• Prior Medication:
• Excluded:
• • More than 24 hours of systemic anti-PCP therapy within 2 weeks prior to study entry.