Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001013
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis Carinii Pneumonia PCP in Patients With AIDS
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 sulfamethoxazoletrimethoprim SMXTMP 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 SMXTMP 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 SMXTMP 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 SMXTMP is given every 6 hours Doses are determined by body size After the first 10 days LCV and SMXTMP 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 patients 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
Patients entered in the study are randomly assigned to TMTX LCV or to SMXTMP 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 SMXTMP is given every 6 hours Doses are determined by body size After the first 10 days LCV and SMXTMP 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 patients 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11005 | REGISTRY | DAIDS ES Registry Number | None |