Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000973
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of Pyrimethamine in the Treatment of Infection by a Certain Parasite in HIV-Positive Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Pyrimethamine Pharmacokinetics in HIV Positive Patients Seropositive for Toxoplasma Gondii
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 determine the manner in which pyrimethamine is metabolized and excreted in patients currently receiving zidovudine AZT An important goal of this measurement is to establish the optimal dose of pyrimethamine necessary to prevent the development of toxoplasmosis in AIDS patients or delay the subsequent return of toxoplasmic encephalitis
Encephalitis caused by Toxoplasma gondii has emerged as the most frequent cause of focal central nervous system infection in patients with AIDS Untreated the encephalitis is fatal The best treatment for this disease has not been determined Presently it is standard practice to administer a combination of pyrimethamine and sulfadiazine Little is known about the pharmacokinetics of pyrimethamine in patients with AIDS receiving AZT Furthermore there are reports that patients already exposed to toxoplasmosis may not have uniform absorption of pyrimethamine
Encephalitis caused by Toxoplasma gondii has emerged as the most frequent cause of focal central nervous system infection in patients with AIDS Untreated the encephalitis is fatal The best treatment for this disease has not been determined Presently it is standard practice to administer a combination of pyrimethamine and sulfadiazine Little is known about the pharmacokinetics of pyrimethamine in patients with AIDS receiving AZT Furthermore there are reports that patients already exposed to toxoplasmosis may not have uniform absorption of pyrimethamine
Detailed Description:
Encephalitis caused by Toxoplasma gondii has emerged as the most frequent cause of focal central nervous system infection in patients with AIDS Untreated the encephalitis is fatal The best treatment for this disease has not been determined Presently it is standard practice to administer a combination of pyrimethamine and sulfadiazine Little is known about the pharmacokinetics of pyrimethamine in patients with AIDS receiving AZT Furthermore there are reports that patients already exposed to toxoplasmosis may not have uniform absorption of pyrimethamine
Patients receive the study treatment for a total of 22 days Patients are given an initial dose of pyrimethamine followed by a lower dose given as a single oral daily dose for 21 days Patients continue to receive AZT at the dose prescribed prior to enrollment in the study Patients receive leucovorin calcium once a day Neither the leucovorin calcium nor the AZT are provided through the study
Patients receive the study treatment for a total of 22 days Patients are given an initial dose of pyrimethamine followed by a lower dose given as a single oral daily dose for 21 days Patients continue to receive AZT at the dose prescribed prior to enrollment in the study Patients receive leucovorin calcium once a day Neither the leucovorin calcium nor the AZT are provided through the study
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 |
|---|---|---|---|
| 11077 | REGISTRY | DAIDS ES Registry Number | None |