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

Completed · Phase 3

Conditions studied: Pneumonia, Pneumocystis Carinii, HIV Infections

In brief

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.

Key facts

Study ID

NCT00001016

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

Expected to finish

2007-08-01

Last updated by the study team

2008-09-30

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Warner-Lambert Parke-Davis — Morris Plains, New Jersey, United States

Full record on ClinicalTrials.gov

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