Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000643
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
1999-11-02
Brief Title:
Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients
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 effectiveness of pyrimethamine given with leucovorin calcium versus placebo an inactive substance for the primary prophylaxis prevention of cerebral toxoplasmosis in HIV-infected patients
Cerebral toxoplasmosis is one of the most frequently encountered opportunistic infections in the course of AIDS The mortality death rate is estimated to be greater than 50 percent Pyrimethamine is a drug that appears promising for the primary prevention of cerebral toxoplasmosis in HIV-infected patients
Cerebral toxoplasmosis is one of the most frequently encountered opportunistic infections in the course of AIDS The mortality death rate is estimated to be greater than 50 percent Pyrimethamine is a drug that appears promising for the primary prevention of cerebral toxoplasmosis in HIV-infected patients
Detailed Description:
Cerebral toxoplasmosis is one of the most frequently encountered opportunistic infections in the course of AIDS The mortality death rate is estimated to be greater than 50 percent Pyrimethamine is a drug that appears promising for the primary prevention of cerebral toxoplasmosis in HIV-infected patients
AMENDED 04-04-91 On the first day of therapy a loading dose is given After the first day patients take pyrimethamine or placebo 3 times a week Patients also take leucovorin calcium orally three times weekly Enrollment occurs over approximately 12 months All patients are followed on study until a common study close-out date and final analysis of the study It is anticipated that this common close-out will occur when the mean duration of time on study therapy will be 3 years approximately in January 1994
ORIGINAL design On the first day of treatment patients receive a loading dose of pyrimethamine or placebo plus of leucovorin calcium After the first day patients take pyrimethamine or placebo three times a week Patients also take folinic acid orally three times weekly The mean duration of study participation is 3 years
AMENDED 04-04-91 On the first day of therapy a loading dose is given After the first day patients take pyrimethamine or placebo 3 times a week Patients also take leucovorin calcium orally three times weekly Enrollment occurs over approximately 12 months All patients are followed on study until a common study close-out date and final analysis of the study It is anticipated that this common close-out will occur when the mean duration of time on study therapy will be 3 years approximately in January 1994
ORIGINAL design On the first day of treatment patients receive a loading dose of pyrimethamine or placebo plus of leucovorin calcium After the first day patients take pyrimethamine or placebo three times a week Patients also take folinic acid orally three times weekly The mean duration of study participation is 3 years
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 |
|---|---|---|---|
| 11129 | REGISTRY | DAIDS ES Registry Number | None |