A Study of Trimetrexate in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS Not Previously Treated for PCP

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and effectiveness of trimetrexate (TMTX) given at increasing doses along with the leucovorin calcium (LCV) for treating Pneumocystis carinii pneumonia (PCP) in AIDS patients TMTX is an experimental new drug which is effective for treatment of PCP, but has been given to only a few patients. Therefore it is not certain if TMTX is better, the same as, or not as effective as conventional drugs against PCP.

Detailed Description
-----------------
TMTX is an experimental new drug which is effective for treatment of PCP, but has been given to only a few patients. Therefore it is not certain if TMTX is better, the same as, or not as effective as conventional drugs against PCP. Increasing doses of TMTX are used in combination with LCV as initial treatment for PCP in 50 AIDS patients. Doses are increased for 21 days on a once daily and then a twice daily basis. Dose escalations occur in subsequent groups of patients.

Official Title
-----------------
Evaluation of Escalating Doses of Intravenous Trimetrexate as Therapy for Previously Untreated Pneumocystis Carinii Pneumonia in AIDS Patients With Subsequent Comparison of Intravenous and Oral Pharmacokinetics

Conditions
-----------------
Pneumonia, Pneumocystis Carinii, HIV Infections

Intervention / Treatment
-----------------
* Drug: Trimetrexate glucuronate
* Drug: Leucovorin calcium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patient must: Have Pneumocystis carinii pneumonia (PCP) that has not been treated for current episode. PCP must be documented by observation of > 1 cluster of organisms in sputum, bronchial secretion, or lung tissue. Have clinical symptoms of respiratory disease or radiologic abnormalities. Exclusion Criteria Patient cannot have significant emotional disorder. Concurrent Medication: Excluded: Drugs likely to be bone marrow toxic. Investigational drugs. Prior Medication: Excluded: Three patients in each group cannot have had zidovudine (AZT) for at least 2 months prior to administration of trimetrexate.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Trimetrexate glucuronate|nan|
|Drug: Leucovorin calcium|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antineoplastic Agents, Trimetrexate, AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Injections, Intravenous, Leucovorin, Dose-Response Relationship, Drug, Drug Therapy, Combination, Folic Acid Antagonists, Administration, Oral, Acquired Immunodeficiency Syndrome