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

Phase 3

Completed

• Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

• Registration Number: NCT00001013
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Detailed Description

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.

Study Timeline

• Study Completion: 1991-09
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 364

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (23)

Los Angeles County - USC Med Ctr; 🇺🇸 Los Angeles, California, United States

George Washington Univ Med Ctr; 🇺🇸 Washington, 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

Bronx Municipal Hosp Ctr/Jacobi Med Ctr; 🇺🇸 Bronx, New York, United States

Jack Weiler Hosp / Bronx Municipal Hosp; 🇺🇸 Bronx, New York, United States

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