Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS

Completed · Phase 3

Conditions studied: Pneumonia, Pneumocystis Carinii, HIV Infections

In brief

To compare the safety and effectiveness of an investigational drug therapy (trimetrexate plus leucovorin calcium) with that of conventional therapy (sulfamethoxazole-trimethoprim) in the treatment of moderately severe Pneumocystis carinii pneumonia (PCP) in patients who have AIDS, are HIV positive, or are at high risk for HIV infection.

Key facts

Study ID

NCT00001013

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

364

Expected to finish

1991-09-01

Last updated by the study team

2021-11-04

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• Acetaminophen:
• 650 mg prescribed as necessary for temperature > 38.7 degrees C. Acetaminophen should not be prescribed as a standing order for more than 48 hours.
• Prior Medication:
• Allowed:
• Zidovudine (AZT) as long as such therapy is suspended prior to randomization and not reinstituted until therapy for the acute episode is completed and the patient's white blood cell count is acceptable.
• Other myelosuppressive therapies which may be handled in the same manner as AZT.
• Prophylaxis for Pneumocystis carinii pneumonia (PCP).
• Unequivocal diagnosis of Pneumocystis carinii pneumonia (PCP) by morphologic confirmation of three or more typical P. carinii organisms in sputum, bronchoalveolar lavage fluid, or lung tissue obtained by transbronchial or open-lung biopsy within 3 days before or after randomization. If morphologic confirmation is not possible prior to therapy, patients may be randomized if the investigator believes there is a high suspicion of PCP based on clinical presentation. If morphologic diagnosis cannot be established within 6 days of randomization, the patient will be withdrawn from study therapy. Resting (A-a) DO2 < 30 torr on room air. Patient, parent, guardian, or person with power of attorney gives informed consent.

You may not qualify if…

• Co-existing Condition:
• Patients will be excluded for the following reasons:
• History of Type I hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reaction secondary to antibiotics containing sulfa, trimethoprim, or trimetrexate.
• History of life-threatening pentamidine toxicity.
• Concurrent Medication:
• Excluded:
• Other drugs for the treatment or prevention of AIDS or Pneumocystis carinii pneumonia (PCP).
• Disalcid.
• Aspirin.
• Acetaminophen q4h as a standing order for more than 48 hours.
• Prior Medication:
• Excluded within 14 days of study entry:
• Systemic steroids exceeding physiological replacement.
• Other investigational drugs including ganciclovir.
• Excluded within 6 weeks of study entry:
• Another antiprotozoal regimen for this episode for therapy of active Pneumocystis carinii pneumonia (PCP).
• Patients who are unable to have arterial blood gas analysis (ABG's) on room air.
• Patients for whom a liter of intravenous fluid (5 percent dextrose in water) per 24 hours, which is required to maintain blinding, would be medically inadvisable.

Where it is running

• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• George Washington Univ Med Ctr — Washington D.C., District of Columbia, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Charity Hosp / Tulane Univ Med School — New Orleans, Louisiana, United States
• Louisiana State Univ Med Ctr / Tulane Med School — New Orleans, Louisiana, United States
• Tulane Univ School of Medicine — New Orleans, Louisiana, United States
• Univ of Massachusetts Med Ctr — Worcester, Massachusetts, United States
• SUNY / Erie County Med Ctr at Buffalo — Buffalo, New York, United States
• City Hosp Ctr at Elmhurst / Mount Sinai Hosp — Elmhurst, New York, United States
• Beth Israel Med Ctr / Peter Krueger Clinic — New York, New York, United States
• Mount Sinai Med Ctr — New York, New York, United States
• Univ of Rochester Medical Center — Rochester, New York, United States
• SUNY - Stony Brook — Stony Brook, New York, United States
• SUNY / State Univ of New York — Syracuse, New York, United States
• Bronx Municipal Hosp Ctr/Jacobi Med Ctr — The Bronx, New York, United States
• Jack Weiler Hosp / Bronx Municipal Hosp — The Bronx, New York, United States
• Montefiore Med Ctr / Bronx Municipal Hosp — The Bronx, New York, United States
• Holmes Hosp / Univ of Cincinnati Med Ctr — Cincinnati, Ohio, United States
• Univ Hosp of Cleveland / Case Western Reserve Univ — Cleveland, Ohio, United States
• Milton S Hershey Med Ctr — Hershey, Pennsylvania, United States
• Thomas Jefferson Med College — Philadelphia, Pennsylvania, United States
• Julio Arroyo — West Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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