Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000666
Status:
COMPLETED
Last Update Posted:
2012-10-29
First Post:
1999-11-02
Brief Title:
A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma Gondii Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma Gondii Infection
Status:
COMPLETED
Status Verified Date:
2012-10
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 pyrimethamine as a prophylactic agent against toxoplasmic encephalitis in individuals who are coinfected with HIV and latent Toxoplasma gondii
Toxoplasmic encephalitis is a major cause of illness and death in AIDS patients Standard treatment for toxoplasmic encephalitis is to combine pyrimethamine and sulfadiazine Continuous treatment is necessary to prevent recurrence of the disease but constant use of pyrimethaminesulfadiazine is associated with toxicity Clindamycin has been shown to be effective in treatment of toxoplasmic encephalitis in animal studies This study evaluates pyrimethamine as a preventive treatment against toxoplasmic encephalitis per 32691 amendment clindamycin arm was discontinued
Toxoplasmic encephalitis is a major cause of illness and death in AIDS patients Standard treatment for toxoplasmic encephalitis is to combine pyrimethamine and sulfadiazine Continuous treatment is necessary to prevent recurrence of the disease but constant use of pyrimethaminesulfadiazine is associated with toxicity Clindamycin has been shown to be effective in treatment of toxoplasmic encephalitis in animal studies This study evaluates pyrimethamine as a preventive treatment against toxoplasmic encephalitis per 32691 amendment clindamycin arm was discontinued
Detailed Description:
Toxoplasmic encephalitis is a major cause of illness and death in AIDS patients Standard treatment for toxoplasmic encephalitis is to combine pyrimethamine and sulfadiazine Continuous treatment is necessary to prevent recurrence of the disease but constant use of pyrimethaminesulfadiazine is associated with toxicity Clindamycin has been shown to be effective in treatment of toxoplasmic encephalitis in animal studies This study evaluates pyrimethamine as a preventive treatment against toxoplasmic encephalitis per 32691 amendment clindamycin arm was discontinued
Patients are randomized to receive pyrimethamine or placebo three times a week All patients must be on aerosolized pentamidine trimethoprim sulfamethoxazole TS or dapsone for Pneumocystis carinii pneumonia prophylaxis Patients will be evaluated bi-weekly for the first month and every other month thereafter for at least 24 months
Patients are randomized to receive pyrimethamine or placebo three times a week All patients must be on aerosolized pentamidine trimethoprim sulfamethoxazole TS or dapsone for Pneumocystis carinii pneumonia prophylaxis Patients will be evaluated bi-weekly for the first month and every other month thereafter for at least 24 months
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?: