Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000998
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of Trimetrexate in the Treatment of Pneumocystis Carinii Pneumonia PCP in Patients With AIDS Not Previously Treated for PCP
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of Escalating Doses of Intravenous Trimetrexate as Therapy for Previously Untreated Pneumocystis Carinii Pneumonia in AIDS Patients With Subsequent Comparison of Intravenous and Oral Pharmacokinetics
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 evaluate the safety and effectiveness of trimetrexate TMTX given at increasing doses along with the leucovorin calcium LCV for treating Pneumocystis carinii pneumonia PCP in AIDS patients TMTX is an experimental new drug which is effective for treatment of PCP but has been given to only a few patients Therefore it is not certain if TMTX is better the same as or not as effective as conventional drugs against PCP
Detailed Description:
TMTX is an experimental new drug which is effective for treatment of PCP but has been given to only a few patients Therefore it is not certain if TMTX is better the same as or not as effective as conventional drugs against PCP
Increasing doses of TMTX are used in combination with LCV as initial treatment for PCP in 50 AIDS patients Doses are increased for 21 days on a once daily and then a twice daily basis Dose escalations occur in subsequent groups of patients
Increasing doses of TMTX are used in combination with LCV as initial treatment for PCP in 50 AIDS patients Doses are increased for 21 days on a once daily and then a twice daily basis Dose escalations occur in subsequent groups of patients
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 |
|---|---|---|---|
| 10994 | REGISTRY | DAIDS ES Registry Number | None |