Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000655
Status:
COMPLETED
Last Update Posted:
2011-03-01
First Post:
1999-11-02
Brief Title:
A Randomized Double-Blind Study of 566C80 Versus Septra SulfamethoxazoleTrimethoprim for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Double-Blind Study of 566C80 Versus Septra TrimethoprimSulfamethoxazole for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients
Status:
COMPLETED
Status Verified Date:
2011-02
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 atovaquone 566C80 compared to a standard antipneumocystis agent SMXTMP for the treatment of mild to moderate Pneumocystis carinii pneumonia PCP in AIDS patients To compare the safety of short-term 21 days treatment with 566C80 and SMXTMP in AIDS patients with an acute episode of PCP
Standard therapies for acute treatment of PCP involve either SMXTMP or pentamidine isetionate Although both treatments are equally effective side effects prevent completion of therapy in 11-55 percent of patients
Standard therapies for acute treatment of PCP involve either SMXTMP or pentamidine isetionate Although both treatments are equally effective side effects prevent completion of therapy in 11-55 percent of patients
Detailed Description:
Standard therapies for acute treatment of PCP involve either SMXTMP or pentamidine isetionate Although both treatments are equally effective side effects prevent completion of therapy in 11-55 percent of patients
Patients are randomized into one of two treatment groups to receive either 1 566C80 for 21 days or 2 SMXTMP for 21 days Patients will be stratified according to severity of PCP Group A will be those with an arterial-alveolar A-a DO2 35 mm Hg Group B will have an A-a DO2 of 35-45 mm Hg and will also be required to receive therapy with Corticosteroids All doses are taken with food During the 21 days of treatment patients are examined clinically for adverse effects and have hematology blood-related and clinical chemistry studies conducted a minimum of 2 times weekly More frequent monitoring may be required at the discretion of the investigator To evaluate the effectiveness of study medication the clinical status of each patient is evaluated 2 to 3 times per week eg dyspnea score cough score chest tightnesspain score vital signs Also on days 7 and 21 of treatment an arterial blood gas measurement and chest X-ray are performed Patients who experience severe toxicities will be discontinued from the study and placed on alternative therapy Patients will also be removed from study if they show significant clinical deterioration within the first 7 days of therapy or if there is no improvement after 10 days of therapy This study involves a double placebo with one group randomized to receive oral 566C80 and placebo tablets which look like SMXTMP while the other group will receive SMXTMP and placebo tablets looking like 566C80
Patients are randomized into one of two treatment groups to receive either 1 566C80 for 21 days or 2 SMXTMP for 21 days Patients will be stratified according to severity of PCP Group A will be those with an arterial-alveolar A-a DO2 35 mm Hg Group B will have an A-a DO2 of 35-45 mm Hg and will also be required to receive therapy with Corticosteroids All doses are taken with food During the 21 days of treatment patients are examined clinically for adverse effects and have hematology blood-related and clinical chemistry studies conducted a minimum of 2 times weekly More frequent monitoring may be required at the discretion of the investigator To evaluate the effectiveness of study medication the clinical status of each patient is evaluated 2 to 3 times per week eg dyspnea score cough score chest tightnesspain score vital signs Also on days 7 and 21 of treatment an arterial blood gas measurement and chest X-ray are performed Patients who experience severe toxicities will be discontinued from the study and placed on alternative therapy Patients will also be removed from study if they show significant clinical deterioration within the first 7 days of therapy or if there is no improvement after 10 days of therapy This study involves a double placebo with one group randomized to receive oral 566C80 and placebo tablets which look like SMXTMP while the other group will receive SMXTMP and placebo tablets looking like 566C80
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 |
|---|---|---|---|
| NIAID 90-CC-185 | None | None | None |
| Protocol 03 | None | None | None |
| FDA 53A | None | None | None |
| Project P71 | None | None | None |