Clinical trial NCT00000998: A Study of Trimetrexate in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS Not Previously Treated for PCP
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pneumonia, Pneumocystis Carinii
HIV Infections
Keywords: 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
Antineoplastic Agents
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County - USC Med Ctr
state: California
Study officials:
name: Masur H
role: STUDY_CHAIR
References:
citation: Sattler FR, Allegra CJ, Verdegem TD, Akil B, Tuazon CU, Hughlett C, Ogata-Arakaki D, Feinberg J, Shelhamer J, Lane HC, et al. Trimetrexate-leucovorin dosage evaluation study for treatment of Pneumocystis carinii pneumonia. J Infect Dis. 1990 Jan;161(1):91-6. doi: 10.1093/infdis/161.1.91.