A Treatment Protocol for the Use of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis Carinii Pneumonia and Serious Intolerance to Approved Therapies

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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.

AMENDED: 08/01/90. As of August 31, 1989, 437 patients were enrolled into uncontrolled studies of trimetr...

Gender

ALL

Eligibility criteria

• • 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.

Trial Officials