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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
This study has been completed.
Sponsored by: | National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
Purpose
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.
Condition | Treatment or Intervention | Phase |
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Pneumonia, Pneumocystis carinii HIV Infections |
Drug: Trimetrexate glucuronate Drug: Pentamidine isethionate Drug: Sulfamethoxazole-Trimethoprim Drug: Leucovorin calcium |
Phase III |
MedlinePlus related topics: AIDS; Fungal Infections; Pneumocystis Carinii Infections; Pneumonia; Respiratory Diseases
Study Type: Interventional
Study Design: Treatment, Parallel Assignment
Official Title: A Randomized, Comparative, Double-Blind Trial of Trimetrexate (CI-898) with Leucovorin Calcium Rescue Versus Trimethoprim / Sulfamethoxazole for Moderately Severe Pneumocystis carinii Pneumonia in Patients with AIDS
Expected Total Enrollment: 364
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
Ages Eligible for Study: 12 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria
Concurrent Medication: Allowed:
Prior Medication: Allowed:
Exclusion Criteria
Co-existing Condition: Patients will be excluded for the following reasons:
Concurrent Medication: Excluded:
Prior Medication: Excluded within 14 days of study entry:
Location Information
More Information
Click here for more information about Pentamidine isethionate
Click here for more information about Sulfamethoxazole-Trimethoprim
Click here for more information about Trimetrexate glucuronate
Publications
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