Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00001013 · ClinicalTrials.gov registry record · Phase 3

Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS

A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 3
Development phase
364
Enrollment target

NCT00001013: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00001013 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 364 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00001013, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 3
Development phase
364 participants
Enrollment target

Study Summary

To compare the safety and effectiveness of an investigational drug therapy (trimetrexate plus leucovorin calcium) with that of conventional therapy (sulfamethoxazole-trimethoprim) in the treatment of moderately severe Pneumocystis carinii pneumonia (PCP) in patients who have AIDS, are HIV positive, or are at high risk for HIV infection.

Interventions

  • DRUG Leucovorin calcium
  • DRUG Pentamidine isethionate
  • DRUG Sulfamethoxazole-Trimethoprim
  • DRUG Trimetrexate glucuronate

Trial Details

FieldValue
Enrollment Target 364 participants
Est. Completion 1991-09
Phase Phase 3

What the finished NCT00001013 record still lists

NCT00001013 is an interventional study that assigns participants to a tested intervention. The registered 364 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower).

The record links to 0 conditions, and to 4 interventions - of which Leucovorin calcium is the first listed.

NCT00001013 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00001013 about?

NCT00001013 is a clinical study titled "Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS". To compare the safety and effectiveness of an investigational drug therapy (trimetrexate plus leucovorin calcium) with that of conventional therapy (sulfamethoxazole-trimethoprim) in the treatment of moderately severe Pneumocystis carinii pneumonia (PCP) in patients who have AIDS, are HIV positive, ...

What is the current status of trial NCT00001013?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 364 participants. Estimated completion is 1991-09.

What interventions are being tested in trial NCT00001013?

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

Who is sponsoring clinical trial NCT00001013?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00001013's enrollment target sits among peer trials

364 1003rd of 2000 higher than 996 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT04510597 · 364 participants · Phase 3

    Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial

  • NCT05098132 · 364 participants · Phase 1

    Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers

  • NCT05330221 · 364 participants · NA

    Project 2: ACHIEVE- HF

  • NCT05673148 · 364 participants · Phase 3

    Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, The ERASur Study

Source: ClinicalTrials.gov NCT00001013, the US trial registry maintained by the National Library of Medicine. NCT00001013 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.