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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.
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
| Field | Value |
|---|---|
| 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.
Learn More About Clinical Trials
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
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