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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000998 |
Purpose
To evaluate the safety and effectiveness of trimetrexate (TMTX) given at increasing doses along with the leucovorin calcium (LCV) for treating Pneumocystis carinii pneumonia (PCP) in AIDS patients TMTX is an experimental new drug which is effective for treatment of PCP, but has been given to only a few patients. Therefore it is not certain if TMTX is better, the same as, or not as effective as conventional drugs against PCP.
| Condition | Intervention | Phase |
|
Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Trimetrexate glucuronate Drug: Leucovorin calcium |
Phase I |
| MedlinePlus related topics: | AIDS Pneumonia |
| Drug Information available for: | Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Folic acid Calcium gluconate Trimetrexate Trimetrexate glucuronate |
| Study Type: | Interventional |
| Study Design: | Treatment, Dose Comparison |
| Official Title: | Evaluation of Escalating Doses of Intravenous Trimetrexate as Therapy for Previously Untreated Pneumocystis Carinii Pneumonia in AIDS Patients With Subsequent Comparison of Intravenous and Oral Pharmacokinetics |
| Estimated Enrollment: | 50 |
TMTX is an experimental new drug which is effective for treatment of PCP, but has been given to only a few patients. Therefore it is not certain if TMTX is better, the same as, or not as effective as conventional drugs against PCP.
Increasing doses of TMTX are used in combination with LCV as initial treatment for PCP in 50 AIDS patients. Doses are increased for 21 days on a once daily and then a twice daily basis. Dose escalations occur in subsequent groups of patients.
Eligibility
| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patient must:
Exclusion Criteria
Concurrent Medication: Excluded:
Prior Medication: Excluded:
Contacts and Locations
More Information
Click here for more information about Trimetrexate glucuronate 
  |
| Study ID Numbers: | ACTG 018 |
| First Received: | November 2, 1999 |
| Last Updated: | September 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000998 |
| Health Authority: | United States: Federal Government |
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