A Treatment Protocol for the Use of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis Carinii Pneumonia and Serious Intolerance to Approved Therapies

NCT00001016 | Completed Phase 3

• 1 other identifier: TX 301
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the safety and effectiveness of an investigational drug trimetrexate (TMTX) with leucovorin rescue (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 demonstrated serious adverse effects from the conventional therapies for PCP. 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 adverse effects. Currently there are no proven alternatives to these drugs. TMTX was chosen for this trial because it has been found to be very active against the PCP organism in laboratory tests. In a preliminary trial, TMTX in combination with LCV has been effective against PCP with fewer and less severe adverse effects.

Conditions

Pneumonia, Pneumocystis Carinii; HIV Infections

Keywords

Trimetrexate; Pneumonia, Pneumocystis carinii; Quinazolines; Infusions, Intravenous; Injections, Intravenous; Leucovorin; Drug Evaluation; Drug Therapy, Combination; Administration, Oral; Acquired Immunodeficiency Syndrome; Antiprotozoal Agents; AIDS-Related Complex

Interventions

Trimetrexate glucuronate DRUG

Leucovorin calcium DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Concurrent Medication:
• Allowed:
• Blood pressure medication.
• Concurrent Treatment:
• Allowed:
• Blood products.
• Ventilatory support.
• Patients must have the following:
• Diagnosis of Pneumocystis carinii pneumonia (PCP).
• Be HIV positive by ELISA, HIV culture, or p24 antigenemia; or be a member of an identified risk group.
• Intolerant to trimethoprim / sulfamethoxazole (TMP / SMX).
• Intolerant to pentamidine.
• Prior Medication:
• Allowed:
• Trimethoprim / sulfamethoxazole trials.

You may not qualify if:

• Co-existing Condition:
• Concurrent Medication:
• Excluded:
• Myelosuppressive agents.
• Nephrotoxic agents.
• Other investigational drugs including high-dose steroids (exceeding physiologic replacement doses).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Warner-Lambert Parke-Davis

Morris Plains, New Jersey, 07950, United States

Location

MeSH Terms

Conditions

Pneumonia, Pneumocystis; HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

trimetrexate glucuronate; Leucovorin

Condition Hierarchy (Ancestors)

Lung Diseases, Fungal; Mycoses; Bacterial Infections and Mycoses; Infections; Pneumocystis Infections; Respiratory Tract Infections; Pneumonia; Lung Diseases; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes

Study Officials

• Feinberg J

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: August 1, 2007
• Last Updated: September 30, 2008

Record last verified: 1993-07

Locations

US (1)