Completed

Phase 1
Age: 18Years - 60Years
All Genders
ID00000998

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

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 1 location

1

Los Angeles County - USC Med Ctr

Los Angeles, California, United States, 90033

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

TREATMENT

Number of Arms

0

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Published Research Related To This Trial

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 | DecenTrialz