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NCT00002120 · ClinicalTrials.gov registry record · Phase 1

Randomized Phase I Study of Trimetrexate Glucuronate (TMTX) With Leucovorin (LCV) Protection Plus Dapsone Versus Trimethoprim / Sulfamethoxazole (TMP/SMX) for Treatment of Moderately Severe Episodes of Pneumocystis Carinii Pneumonia

A Phase 1 study, sponsored by U.S. Bioscience.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target

NCT00002120 is a Phase 1 study that has completed, run by U.S. Bioscience. The registered enrollment target is 20 participants.

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The verdict

NCT00002120, a Phase 1 study, has completed, sponsored by U.S. Bioscience.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study Summary

To evaluate the safety of the combination of trimetrexate glucuronate (TMTX) and dapsone with leucovorin protection versus trimethoprim/sulfamethoxazole (TMP/SMX) in patients with AIDS and moderately severe Pneumocystis carinii pneumonia (PCP). To determine the pharmacokinetic parameters of TMTX, leucovorin, and dapsone and of TMP/SMX when given to patients with AIDS and moderately severe PCP.

Interventions

  • DRUG Leucovorin calcium
  • DRUG Dapsone
  • DRUG Trimetrexate glucuronate
  • DRUG Trimethoprim
  • DRUG Sulfamethoxazole

Trial Details

FieldValue
Enrollment Target 20 participants
Phase Phase 1

Sponsor

U.S. Bioscience

5 total trials

What the Registry Record Tells You About NCT00002120

The ClinicalTrials.gov registry entry for NCT00002120 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is U.S. Bioscience, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Leucovorin calcium is the first listed.

NCT00002120 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00002120 about?

NCT00002120 is a clinical study titled "Randomized Phase I Study of Trimetrexate Glucuronate (TMTX) With Leucovorin (LCV) Protection Plus Dapsone Versus Trimethoprim / Sulfamethoxazole (TMP/SMX) for Treatment of Moderately Severe Episodes of Pneumocystis Carinii Pneumonia". To evaluate the safety of the combination of trimetrexate glucuronate (TMTX) and dapsone with leucovorin protection versus trimethoprim/sulfamethoxazole (TMP/SMX) in patients with AIDS and moderately severe Pneumocystis carinii pneumonia (PCP). To determine the pharmacokinetic parameters of TMTX, le...

What is the current status of trial NCT00002120?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants.

What interventions are being tested in trial NCT00002120?

The interventions under investigation include: Leucovorin calcium (DRUG), Dapsone (DRUG), Trimetrexate glucuronate (DRUG), Trimethoprim (DRUG), Sulfamethoxazole (DRUG).

Who is sponsoring clinical trial NCT00002120?

This trial is sponsored by U.S. Bioscience, which has 5 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.