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NCT00001014 · ClinicalTrials.gov registry record · Phase 3
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
- 302
- Enrollment target
NCT00001014 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 302 participants.
The verdict
NCT00001014, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 302 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. New treatments are needed to reduce the mortality rate from PCP in AIDS patients and to reduce the high relapse rate found after conventional therapy. Trimetrexate (TMTX) was chosen for this trial because it was found to be much more potent than sulfamethoxazole/trimethoprim (SMX/TMP) against the PCP organism in laboratory tests. Also TMTX, in combination with leucovorin (LCV), did not cause severe toxicity in a preliminary trial. It is believed that TMTX will be more effective in treating PCP and in preventing a recurrence of PCP.
Interventions
- DRUG Leucovorin calcium
- DRUG Sulfamethoxazole-Trimethoprim
- DRUG Trimetrexate glucuronate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Est. Completion | 1991-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001014
The ClinicalTrials.gov registry entry for NCT00001014 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 302 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Leucovorin calcium is the first listed.
NCT00001014 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001014 about?
NCT00001014 is a clinical study titled "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 NCT00001014?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 302 participants. Estimated completion is 1991-09.
What interventions are being tested in trial NCT00001014?
The interventions under investigation include: Leucovorin calcium (DRUG), Sulfamethoxazole-Trimethoprim (DRUG), Trimetrexate glucuronate (DRUG).
Who is sponsoring clinical trial NCT00001014?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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