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An Open, Prospective, Multicenter Study of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis Carinii Pneumonia (PCP) and Serious Intolerance to Approved Therapies
NCT00000714 · View on ClinicalTrials.gov ↗
Study Summary
To determine the safety and effectiveness of an investigational drug therapy (trimetrexate plus leucovorin calcium (TMTX / LCV)) in the treatment of Pneumocystis carinii pneumonia (PCP) in patients who have AIDS, are HIV positive, or are at high risk for HIV infection, and who have suffered severe or life-threatening ill effects from both conventional therapies for PCP. AMENDED: 08/01/90 As of August 31, 1989, 437 patients were enrolled into uncontrolled studies of trimetrexate for PCP:214 in TX 301/ACTG 0=039 (trimetrexate for patients intolerant of approved therapies) and 223 in NS 401 (trimetrexate for patients refractory to approved therapies). The analysis of overall response rate, stringently defined as having received at least 14 days of trimetrexate and being alive at follow-up 1 month after the completion of therapy, reveals 84/159 intolerant patients and 48/160 refractory patients had responded, for rates of 53 percent and 30 percent, respectively. These response rates include all individuals who received at least one dose of trimetrexate. Of the 111 patients who were ventilator-dependent at study entry, 18 completed a course of therapy and were alive a month later, for a response rate of 16 percent. All other ventilated patients died. The most common severe (grades 3 and 4) toxicities were: transaminase elevation (\> 5 x normal) in 94 patients, anemia (\< 7.9 g/dl) in 109, neutropenia (\< 750 cells/mm3) in 58, fever (\> 40 C) in 37, and thrombocytopenia (\< 50000 platelets/mm3) in 27. Toxicity required discontinuation of therapy in approximately 5 percent of all patients. Original design: The drugs usually used to treat PCP in AIDS patients, trimethoprim / sulfamethoxazole and pentamidine, have had to be discontinued in many patients because of severe side effects. Currently there are no proven alternatives to these drugs. TMTX was chosen for this trial because it was found to be very active against the PCP organism in laboratory tests. Also TMTX, in com
Conditions Studied
Interventions
- DRUG Leucovorin calcium
- DRUG Trimetrexate glucuronate
Study Locations (20)
New York
- SUNY / Erie County Med Ctr at Buffalo — Buffalo
- City Hosp Ctr at Elmhurst / Mount Sinai Hosp — Elmhurst
- Beth Israel Med Ctr — New York
- Bellevue Hosp / New York Univ Med Ctr — New York
- Mount Sinai Med Ctr — New York
- Univ of Rochester Medical Center — Rochester
- SUNY - Stony Brook — Stony Brook
- Bronx Municipal Hosp Ctr/Jacobi Med Ctr — The Bronx
- Montefiore Med Ctr / Bronx Municipal Hosp — The Bronx
Massachusetts
- Beth Israel Deaconess - West Campus — Boston
- Univ of Massachusetts Med Ctr — Worcester
Florida
- Univ of Miami School of Medicine — Miami
Illinois
- Northwestern Univ Med School — Chicago
Indiana
- Indiana Univ Hosp — Indianapolis
Louisiana
- Tulane Univ School of Medicine — New Orleans
Maryland
- Johns Hopkins Hosp — Baltimore
New Jersey
- Warner-Lambert Parke-Davis — Morris Plains
Trial Details
| Field | Value |
|---|---|
| Est. Completion | 2004-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000714
The ClinicalTrials.gov registry entry for NCT00000714 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 2 interventions — of which Leucovorin calcium is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00000714 reports 20 study locations spanning 11 distinct geographic areas — top geographies include New York, Massachusetts, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00000714 about?
NCT00000714 is a clinical study titled "An Open, Prospective, Multicenter Study of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis Carinii Pneumonia (PCP) and Serious Intolerance to Approved Therapies". To determine the safety and effectiveness of an investigational drug therapy (trimetrexate plus leucovorin calcium (TMTX / LCV)) in the treatment of Pneumocystis carinii pneumonia (PCP) in patients who have AIDS, are HIV positive, or are at high risk for HIV infection, and who have suffered severe o...
What is the current status of trial NCT00000714?
This trial is currently completed. It is a Phase 3 study. Estimated completion is 2004-07.
What conditions does trial NCT00000714 study?
This clinical trial studies the following conditions: HIV Infections, Pneumonia, Pneumocystis Carinii. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00000714?
The interventions under investigation include: Leucovorin calcium (DRUG), Trimetrexate glucuronate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00000714?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00000714 being conducted?
This trial has 20 study locations across Florida, Illinois, Indiana, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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