A Study of Trimetrexate in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS Not Previously Treated for PCP

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00000998
• Collaborator: (none)
• Enrollment: 50
• Location: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia, Pneumocystis Carinii; HIV Infections	Drug: Trimetrexate glucuronate; Drug: Leucovorin calcium	Phase 1

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 Design

• Study Type: Interventional
• Primary Purpose: Treatment
• 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
• Actual Study Completion Date: Apr 1, 1989

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Los Angeles County - USC Med Ctr	Los Angeles	California	United States	90033

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Study Chair: Masur H,

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT00000998
• Other Study ID Numbers: ACTG 018; 10994
• First Posted: Aug 31, 2001
• Last Update Posted: Nov 4, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID): 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
• Additional relevant MeSH terms: Pneumonia; Pneumonia, Pneumocystis; Leucovorin; Trimetrexate; Calcium; Levoleucovorin

Study Results

No Results Posted as of Nov 4, 2021