EICHORCondition: Pneumonia, Pneumocystis Carinii · HIV Infections · Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
To determine the safety and effectiveness of an investigational drug trimetrexate (TMTX) with leucovorin rescue (LCV) in the treatment of Pneumocystis carinii pneumonia (PCP) in patients who have AIDS, are HIV positive, or are at high risk for HIV infection, and who have demonstrated serious adverse effects from the conventional therapies for PCP. The drugs usually used to treat PCP in AIDS patients (trimethoprim / sulfamethoxazole and pentamidine) have had to be discontinued in many patients because of severe adverse effects. Currently there are no proven alternatives to these drugs. TMTX was chosen for this trial because it has been found to be very active against the PCP organism in laboratory tests. In a preliminary trial, TMTX in combination with LCV has been effective against PCP with fewer and less severe adverse effects.
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Inclusion Criteria Concurrent Medication: Allowed: * Blood pressure medication. Concurrent Treatment: Allowed: * Blood products. * Ventilatory support. Patients must have the following: * Diagnosis of Pneumocystis carinii pneumonia (PCP). * Be HIV positive by ELISA, HIV culture, or p24 antigenemia; or be a member of an identified risk group. * Intolerant to trimethoprim / sulfamethoxazole (TMP / SMX). * Intolerant to pentamidine. Prior Medication: Allowed: * Trimethoprim / sulfamethoxazole trials. * Pentamidine trials. * Myelosuppressive agents. * Nephrotoxic agents. * Zidovudine (AZT). Exclusion Criteria Co-existing Condition: Patients who do not meet the inclusion criteria are excluded. Concurrent Medication: Excluded: * Myelosuppressive agents. * Nephrotoxic agents. * Other investigational drugs including high-dose steroids (exceeding physiologic replacement doses). Patients who do not meet the inclusion criteria are excluded.
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| Warner-Lambert Parke-Davis | Morris Plains, New Jersey, United States | — |
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Source record: clinicaltrials.gov/study/NCT00001016