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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: Completed Phase 1 study, sponsored by U.S. Bioscience.

NCT00002120 is a Phase 1 study that has completed, run by U.S. Bioscience. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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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
U.S. Bioscience

5 total trials

What the finished NCT00002120 record still lists

NCT00002120 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).

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

NCT00002120 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00002120's enrollment target sits among peer trials

20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00002120, the US trial registry maintained by the National Library of Medicine. NCT00002120 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.