Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000730
Status:
TERMINATED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
Comparison of Three Treatments for Pneumocystis Pneumonia in AIDS Patients
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 Trial of Trimetrexate With Leucovorin Rescue Versus Standard Anti-Pneumocystis Therapy Versus Standard Anti-Pneumocystis Therapy With High Dose Steroids for AIDS Patients With Pneumocystis Pneumonia Who Appear to Be Refractory to Conventional Drugs
Status:
TERMINATED
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:
This study compares three different therapies for treatment of refractory Pneumocystis carinii pneumonia PCP in patients with AIDS Refractory means that the patient has failed to respond to at least 4 days of treatment with either of two standard therapies 1 sulfamethoxazoletrimethoprim SMXTMP or 2 pentamidine PEN This study compares therapy with trimetrexate TMTX and leucovorin LCV to standard therapy and standard therapy plus high-dose steroids methylprednisolone The purpose is to find better and safer forms of treatment for PCP in AIDS patients There is at present no scientific information about the best treatment for an AIDS patient with PCP who is not improving while receiving the standard therapies SMXTMP or PEN New drug treatments are available including steroid therapy and TMTX but there is no information proving that these new treatments work better than the standard therapies
Detailed Description:
There is at present no scientific information about the best treatment for an AIDS patient with PCP who is not improving while receiving the standard therapies SMXTMP or PEN New drug treatments are available including steroid therapy and TMTX but there is no information proving that these new treatments work better than the standard therapies
Hospitalized patients who have failed to respond to at least 4 full days but no greater than 14 full days of therapy with SMXTMP or PEN are randomly placed into one of three study groups Patients are stratified for 1 mechanical ventilation at enrollment 2 prior zidovudine therapy of at least 4 weeks duration and 3 first versus subsequent episode of PCP One group of patients receives TMTX by intravenous infusion for 21 days and LCV for 24 days The second and third group of patients receive either PEN or SMXTMP depending on which therapy they have already received and not improved on The difference between the second and third group is that the second group receives the conventional therapy PEN or SMXTMP and a placebo inactive medication and the third group receives the conventional therapy and prednisolone Neither investigators nor patients know whether patients receive methylprednisolone Patients continue study treatment until a study end point is reached or for a minimum of 21 days unless there is toxicity
Hospitalized patients who have failed to respond to at least 4 full days but no greater than 14 full days of therapy with SMXTMP or PEN are randomly placed into one of three study groups Patients are stratified for 1 mechanical ventilation at enrollment 2 prior zidovudine therapy of at least 4 weeks duration and 3 first versus subsequent episode of PCP One group of patients receives TMTX by intravenous infusion for 21 days and LCV for 24 days The second and third group of patients receive either PEN or SMXTMP depending on which therapy they have already received and not improved on The difference between the second and third group is that the second group receives the conventional therapy PEN or SMXTMP and a placebo inactive medication and the third group receives the conventional therapy and prednisolone Neither investigators nor patients know whether patients receive methylprednisolone Patients continue study treatment until a study end point is reached or for a minimum of 21 days unless there is toxicity
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 |
|---|---|---|---|
| 11006 | REGISTRY | DAIDS ES Registry Number | None |