Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000966
Status:
COMPLETED
Last Update Posted:
2008-08-26
First Post:
1999-11-02
Brief Title:
A Study of Azithromycin Plus Pyrimethamine in the Treatment of a Brain Infection in Patients With AIDS
Sponsor:
Pfizer
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Dose-Escalation Phase III Study of Oral Azithromycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS
Status:
COMPLETED
Status Verified Date:
1994-10
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 and toxicity of oral azithromycin and pyrimethamine as acute therapy for toxoplasmic encephalitis in AIDS patients To assess the toxicity and effectiveness of azithromycin alone as maintenance therapy
Encephalitis caused by Toxoplasma gondii is the most frequent cause of focal central nervous system infection in patients with AIDS Untreated the encephalitis is fatal Standard treatment for toxoplasmic encephalitis is associated with serious adverse effects Thus alternative treatments are needed
Encephalitis caused by Toxoplasma gondii is the most frequent cause of focal central nervous system infection in patients with AIDS Untreated the encephalitis is fatal Standard treatment for toxoplasmic encephalitis is associated with serious adverse effects Thus alternative treatments are needed
Detailed Description:
Encephalitis caused by Toxoplasma gondii is the most frequent cause of focal central nervous system infection in patients with AIDS Untreated the encephalitis is fatal Standard treatment for toxoplasmic encephalitis is associated with serious adverse effects Thus alternative treatments are needed
Patients with toxoplasmosis are given azithromycin at doses starting at the lowest dose for the first cohort an intermediate dose for the second cohort and a higher dose for the third cohort Subsequent cohorts may receive azithromycin in increased dosage if needed to determine the MTD All patients also receive pyrimethamine Folinic acid is also provided for as long as patients receive pyrimethamine Patients are evaluated for clinical response to treatment at days 3 7 and 14 and weekly for 6 weeks Maintenance treatment with azithromycin continues for an additional 24 weeks Patients who complete the study period without relapse or significant toxicity are offered continued therapy by the drug company and are followed for survival and relapse on a monthly basis for 1 year After the MTD is determined a subsequent cohort may be added for special studies
Patients with toxoplasmosis are given azithromycin at doses starting at the lowest dose for the first cohort an intermediate dose for the second cohort and a higher dose for the third cohort Subsequent cohorts may receive azithromycin in increased dosage if needed to determine the MTD All patients also receive pyrimethamine Folinic acid is also provided for as long as patients receive pyrimethamine Patients are evaluated for clinical response to treatment at days 3 7 and 14 and weekly for 6 weeks Maintenance treatment with azithromycin continues for an additional 24 weeks Patients who complete the study period without relapse or significant toxicity are offered continued therapy by the drug company and are followed for survival and relapse on a monthly basis for 1 year After the MTD is determined a subsequent cohort may be added for special studies
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?: