Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS
NCT ID: NCT00001013
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
364 participants
INTERVENTIONAL
1991-09-30
Brief Summary
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Detailed Description
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Patients entered in the study are randomly assigned to TMTX / LCV or to SMX/TMP for a 21-day trial. For the first 10 days, the trial is double-blind (neither patient nor physician knows which drugs the patient is receiving), and drugs are given by intravenous infusion. TMTX is given once every 24 hours and LCV every 6 hours; SMX/TMP is given every 6 hours. Doses are determined by body size. After the first 10 days, LCV and SMX/TMP may be given orally. Doses are adjusted or treatment is changed to intravenous PEN if side effects are too severe. During the 21-day trial, zidovudine (AZT) may not be used because of possible increased bone marrow toxicity. AZT may be resumed as soon as the patient's white cell count is acceptable. Aerosolized PEN therapy is begun 7 - 10 days after completion of therapy for the acute episode. PEN is inhaled once weekly for 4 weeks, then every 2 weeks for 48 weeks.
Conditions
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Keywords
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Study Design
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PARALLEL
TREATMENT
Interventions
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Trimetrexate glucuronate
Pentamidine isethionate
Sulfamethoxazole-Trimethoprim
Leucovorin calcium
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
12 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Sattler FR
Role: STUDY_CHAIR
Locations
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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
Countries
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References
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Sattler FR, Frame P, Davis R, Nichols L, Shelton B, Akil B, Baughman R, Hughlett C, Weiss W, Boylen CT, et al. Trimetrexate with leucovorin versus trimethoprim-sulfamethoxazole for moderate to severe episodes of Pneumocystis carinii pneumonia in patients with AIDS: a prospective, controlled multicenter investigation of the AIDS Clinical Trials Group Protocol 029/031. J Infect Dis. 1994 Jul;170(1):165-72. doi: 10.1093/infdis/170.1.165.
Other Identifiers
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11005
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 029
Identifier Type: -
Identifier Source: org_study_id