Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000794
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis
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 efficacy safety and tolerance of atovaquone with either pyrimethamine or sulfadiazine in AIDS patients with toxoplasmic encephalitis
AIDS patients with toxoplasmic encephalitis who receive the standard therapy combination of sulfadiazine and pyrimethamine experience a high frequency of severe toxicity Atovaquone an antibiotic that has demonstrated efficacy against toxoplasmosis in animal models and in preclinical testing has been well tolerated is now available as a suspension which is more readily absorbed than the tablet form of the drug The efficacy and safety of atovaquone in combination with sulfadiazine or pyrimethamine will be studied
AIDS patients with toxoplasmic encephalitis who receive the standard therapy combination of sulfadiazine and pyrimethamine experience a high frequency of severe toxicity Atovaquone an antibiotic that has demonstrated efficacy against toxoplasmosis in animal models and in preclinical testing has been well tolerated is now available as a suspension which is more readily absorbed than the tablet form of the drug The efficacy and safety of atovaquone in combination with sulfadiazine or pyrimethamine will be studied
Detailed Description:
AIDS patients with toxoplasmic encephalitis who receive the standard therapy combination of sulfadiazine and pyrimethamine experience a high frequency of severe toxicity Atovaquone an antibiotic that has demonstrated efficacy against toxoplasmosis in animal models and in preclinical testing has been well tolerated is now available as a suspension which is more readily absorbed than the tablet form of the drug The efficacy and safety of atovaquone in combination with sulfadiazine or pyrimethamine will be studied
Seventy patients are randomized to receive atovaquone with either pyrimethamine or sulfonamides for up to 48 weeks Additionally three cohorts of 10 patients each who have a history of treatment-limiting toxicity to pyrimethamine sulfadiazine or both drugs receive atovaquone plus the alternate drug or atovaquone plus clarithromycin All patients receiving pyrimethamine also receive leucovorin protection
PER AMENDMENT 4396
The open treatment groups are Atovaquone plus pyrimethamine for patients with acute toxoplasmic encephalitis who have no treatment limiting toxicity to pyrimethamine and Atovaquone plus clarithromycin for patients with acute toxoplasmic encephalitis who have treatment limiting toxicity to both pyrimethamine and sulfadiazine The following arms closed on 122295 Randomization to the atovaquone plus sulfadiazine arm for patients with acute toxoplasmic encephalitis who had no treatment limiting toxicity to pyrimethamine or sulfonamides and Atovaquone plus sulfadiazine for patients with acute toxoplasmic encephalitis who had treatment limiting toxicity to pyrimethamine The following arm closed on 92695 Atovaquone plus pyrimethamine for patients with acute toxoplasmic encephalitis who had treatment limiting toxicity to sulfonamides NOTE Any patients enrolled in previous versions will continue to be treated with that same drug treatment and followed under their previous version guidelines
Seventy patients are randomized to receive atovaquone with either pyrimethamine or sulfonamides for up to 48 weeks Additionally three cohorts of 10 patients each who have a history of treatment-limiting toxicity to pyrimethamine sulfadiazine or both drugs receive atovaquone plus the alternate drug or atovaquone plus clarithromycin All patients receiving pyrimethamine also receive leucovorin protection
PER AMENDMENT 4396
The open treatment groups are Atovaquone plus pyrimethamine for patients with acute toxoplasmic encephalitis who have no treatment limiting toxicity to pyrimethamine and Atovaquone plus clarithromycin for patients with acute toxoplasmic encephalitis who have treatment limiting toxicity to both pyrimethamine and sulfadiazine The following arms closed on 122295 Randomization to the atovaquone plus sulfadiazine arm for patients with acute toxoplasmic encephalitis who had no treatment limiting toxicity to pyrimethamine or sulfonamides and Atovaquone plus sulfadiazine for patients with acute toxoplasmic encephalitis who had treatment limiting toxicity to pyrimethamine The following arm closed on 92695 Atovaquone plus pyrimethamine for patients with acute toxoplasmic encephalitis who had treatment limiting toxicity to sulfonamides NOTE Any patients enrolled in previous versions will continue to be treated with that same drug treatment and followed under their previous version guidelines
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 |
|---|---|---|---|
| ANRS 039 | None | None | None |
| 11214 | REGISTRY | DAIDS-ES | None |