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Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS Clinical research trials and Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS. Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS clinical trial. Test subjects typically obtain the finest healthcare available for their Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS  Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS
Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS
For Condition: Pneumonia, Pneumocystis carinii,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: New treatments are needed to reduce the mortality rate from PCP in AIDS patients and to reduce the high relapse rate found after conventional therapy. Trimetrexate (TMTX) was chosen for this trial because it was found to be much more potent than sulfamethoxazole/trimethoprim (SMX/TMP) against the PCP organism in laboratory tests. Also TMTX, in combination with leucovorin (LCV), did not cause severe toxicity in a preliminary trial. It is believed that TMTX will be more effective than SMX/TMP in treating PCP and in preventing a recurrence of PCP. Preliminary studies suggest that aerosolized pentamidine (PEN) is likely to be effective in preventing a recurrence of PCP. 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.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria 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. Exclusion Criteria 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.
Total Enrollment: 364
Location and Contact Information:
Overall Study Official:
SattlerFR, Study Chair,
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York City, New York, 10003
United States
Thomas Jefferson Med College
Philadelphia, Pennsylvania, 19107
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
SUNY - Stony Brook
Stony Brook, New York, 117948153
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Additional Information:
Study ID Numbers: ACTG 029;
Study Start Date:
Record last reviewed: April 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001013
Other Hiv Infections Studies:
1. Phase I Safety and Pharmacokinetics Study of Microparticulate Atovaquone (m-Atovaquone; 566C80) in HIV-Infected and Perinatally Exposed Infants and Children.
2. Randomized Phase I Study of Trimetrexate Glucuronate (TMTX) With Leucovorin (LCV) Protection Plus Dapsone Versus Trimethoprim / Sulfamethoxazole (TMP/SMX) for Treatment of Moderately Severe Episodes of Pneumocystis carinii Pneumonia
3. A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate (Neutrexin) With Leucovorin Protection for European Adult Patients (>= 13 Years Old) With Pneumocystis carinii Pneumonia
4. A Study of Trimetrexate Plus Leucovorin in Children with Pneumocystis Carinii Pneumonia
5. A Study of WR 6026 in the Treatment of Pneumocystis carinii Pneumonia (PCP) in HIV-Infected Patients
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Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS
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