- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000998
A Study of Trimetrexate in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS Not Previously Treated for PCP
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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California
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Los Angeles, California, United States, 90033
- Los Angeles County - USC Med Ctr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Investigators
- Study Chair: Masur H
Publications and helpful links
Study record dates
Study Major Dates
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Bacterial Infections and Mycoses
- Mycoses
- Lung Diseases, Fungal
- Pneumocystis Infections
- Pneumonia
- Pneumonia, Pneumocystis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Protective Agents
- Micronutrients
- Vitamins
- Calcium-Regulating Hormones and Agents
- Antifungal Agents
- Antidotes
- Vitamin B Complex
- Folic Acid Antagonists
- Leucovorin
- Calcium
- Levoleucovorin
- Trimetrexate
Other Study ID Numbers
- ACTG 018
- 10994 (REGISTRY: DAIDS ES Registry Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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