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CompletedNCT00000998Updated Nov 4, 2021

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

A Phase 1 interventional study of Trimetrexate glucuronate and Leucovorin calcium in Pneumonia, Pneumocystis Carinii and HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-11-04.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
50
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
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In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 50 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Enrollment
50 participants

Interventions

  • DrugTrimetrexate glucuronate
  • DrugLeucovorin calcium
06

Study locations

1 site
  • Los Angeles County - USC Med Ctr
    Los Angeles, California 90033, United States
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References and documents

Publications

  • 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. PubMed 2136905 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00000998
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
Aug 31, 2001
Completion
Apr 1989
Last update
Nov 4, 2021

Study contacts

Masur H
study chair
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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