Back to resultsA Study of Trimetrexate in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS Not Previously Treated for PCP
Primary Purpose
Pneumonia, Pneumocystis Carinii, HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Trimetrexate glucuronate
Leucovorin calcium
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia, Pneumocystis Carinii focused on measuring Trimetrexate, AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Injections, Intravenous, Leucovorin, Dose-Response Relationship, Drug, Drug Therapy, Combination, Folic Acid Antagonists, Administration, Oral, Acquired Immunodeficiency Syndrome, Antineoplastic Agents
Eligibility Criteria
Inclusion Criteria Patient must: Have Pneumocystis carinii pneumonia (PCP) that has not been treated for current episode. PCP must be documented by observation of > 1 cluster of organisms in sputum, bronchial secretion, or lung tissue. Have clinical symptoms of respiratory disease or radiologic abnormalities. Exclusion Criteria Patient cannot have significant emotional disorder. Concurrent Medication: Excluded: Drugs likely to be bone marrow toxic. Investigational drugs. Prior Medication: Excluded: Three patients in each group cannot have had zidovudine (AZT) for at least 2 months prior to administration of trimetrexate.
Sites / Locations
- Los Angeles County - USC Med Ctr
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000998
First Posted
November 2, 1999
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00000998
Brief Title
A Study of Trimetrexate in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS Not Previously Treated for PCP
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 1989 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumocystis Carinii, HIV Infections
Keywords
Trimetrexate, AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Injections, Intravenous, Leucovorin, Dose-Response Relationship, Drug, Drug Therapy, Combination, Folic Acid Antagonists, Administration, Oral, Acquired Immunodeficiency Syndrome, Antineoplastic Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Trimetrexate glucuronate
Intervention Type
Drug
Intervention Name(s)
Leucovorin calcium
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patient must:
Have Pneumocystis carinii pneumonia (PCP) that has not been treated for current episode. PCP must be documented by observation of > 1 cluster of organisms in sputum, bronchial secretion, or lung tissue.
Have clinical symptoms of respiratory disease or radiologic abnormalities.
Exclusion Criteria
Patient cannot have significant emotional disorder.
Concurrent Medication: Excluded:
Drugs likely to be bone marrow toxic.
Investigational drugs.
Prior Medication: Excluded:
Three patients in each group cannot have had zidovudine (AZT) for at least 2 months prior to administration of trimetrexate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masur H
Official's Role
Study Chair
Facility Information:
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
2136905
Citation
Sattler FR, Allegra CJ, Verdegem TD, Akil B, Tuazon CU, Hughlett C, Ogata-Arakaki D, Feinberg J, Shelhamer J, Lane HC, et al. Trimetrexate-leucovorin dosage evaluation study for treatment of Pneumocystis carinii pneumonia. J Infect Dis. 1990 Jan;161(1):91-6. doi: 10.1093/infdis/161.1.91.
Results Reference
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A Study of Trimetrexate in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS Not Previously Treated for PCP
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