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

Completed · Phase 1

Conditions studied: Pneumonia, Pneumocystis Carinii, HIV Infections

In brief

To evaluate the safety of the combination of trimetrexate glucuronate (TMTX) and dapsone with leucovorin protection versus trimethoprim/sulfamethoxazole (TMP/SMX) in patients with AIDS and moderately severe Pneumocystis carinii pneumonia (PCP). To determine the pharmacokinetic parameters of TMTX, leucovorin, and dapsone and of TMP/SMX when given to patients with AIDS and moderately severe PCP.

Key facts

Study ID

NCT00002120

Run by

U.S. Bioscience

People needed

20

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Los Angeles County / Health Research Assoc / Drew Med Ctr — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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