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

NCT00001013 | Completed Phase 3

• 2 other identifiers: ACTG 02911005
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 23

Brief Summary

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.

Conditions

Pneumonia, Pneumocystis Carinii; HIV Infections

Keywords

Trimethoprim-Sulfamethoxazole Combination; Trimetrexate; AIDS-Related Opportunistic Infections; Pneumonia, Pneumocystis carinii; Pentamidine; Infusions, Intravenous; Leucovorin; Drug Therapy, Combination; Folic Acid Antagonists; Aerosols; Acquired Immunodeficiency Syndrome; Antiprotozoal Agents; AIDS-Related Complex; Sulfamethoxazole-Trimethoprim

Interventions

Trimetrexate glucuronate DRUG

Pentamidine isethionate DRUG

Sulfamethoxazole-Trimethoprim 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:
• Acetaminophen:
• 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:

Sponsors & Collaborators

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

Study Sites (23)

Los Angeles County - USC Med Ctr

Los Angeles, California, 90033, United States

Location

George Washington Univ Med Ctr

Washington D.C., District of Columbia, 20037, United States

Location

Univ of Miami School of Medicine

Miami, Florida, 331361013, United States

Location

Northwestern Univ Med School

Chicago, Illinois, 60611, United States

Location

Charity Hosp / Tulane Univ Med School

New Orleans, Louisiana, 70112, United States

Location

Louisiana State Univ Med Ctr / Tulane Med School

New Orleans, Louisiana, 70112, United States

Location

Tulane Univ School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Univ of Massachusetts Med Ctr

Worcester, Massachusetts, 01655, United States

Location

SUNY / Erie County Med Ctr at Buffalo

Buffalo, New York, 14215, United States

Location

City Hosp Ctr at Elmhurst / Mount Sinai Hosp

Elmhurst, New York, 11373, United States

Location

Beth Israel Med Ctr / Peter Krueger Clinic

New York, New York, 10003, United States

Location

Mount Sinai Med Ctr

New York, New York, 10029, United States

Location

Univ of Rochester Medical Center

Rochester, New York, 14642, United States

Location

SUNY - Stony Brook

Stony Brook, New York, 117948153, United States

Location

SUNY / State Univ of New York

Syracuse, New York, 13210, United States

Location

Bronx Municipal Hosp Ctr/Jacobi Med Ctr

The Bronx, New York, 10461, United States

Location

Jack Weiler Hosp / Bronx Municipal Hosp

The Bronx, New York, 10465, United States

Location

Montefiore Med Ctr / Bronx Municipal Hosp

The Bronx, New York, 10467, United States

Location

Holmes Hosp / Univ of Cincinnati Med Ctr

Cincinnati, Ohio, 452670405, United States

Location

Univ Hosp of Cleveland / Case Western Reserve Univ

Cleveland, Ohio, 44106, United States

Location

Milton S Hershey Med Ctr

Hershey, Pennsylvania, 170330850, United States

Location

Thomas Jefferson Med College

Philadelphia, Pennsylvania, 19107, United States

Location

Julio Arroyo

West Columbia, South Carolina, 29169, United States

Location

Related Publications (1)

• 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.

  PMID: 8014493 BACKGROUND

MeSH Terms

Conditions

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

Interventions

trimetrexate glucuronate; Pentamidine; Trimethoprim, Sulfamethoxazole Drug Combination; 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; Opportunistic Infections; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Benzamidines; Amidines; Organic Chemicals; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Sattler FR

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: September 1, 1991
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (23)