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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Completion Date

1989-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pneumonia, Pneumocystis Carinii HIV Infections

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Trimetrexate glucuronate

Intervention Type DRUG

Leucovorin calcium

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Masur H

Role: STUDY_CHAIR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Los Angeles County - USC Med Ctr

Los Angeles, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND

PMID: 2136905 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10994

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACTG 018

Identifier Type: -

Identifier Source: org_study_id