Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001028
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
A Study of Pentamidine Plus Dapsone in the Prevention of Pneumocystis Carinii Pneumonia PCP in HIV-Infected Patients Who Cannot Take Trimethoprim or Sulfonamides
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Comparative Prospective Study of Monthly Aerosolized Pentamidine and Thrice Weekly Dapsone for Prophylaxis Against PCP in HIV-Infected Patients Who Are Intolerant to Trimethoprim andor Sulfonamides
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 compare the safety and efficacy of aerosolized pentamidine and dapsone in the prevention of Pneumocystis carinii pneumonia PCP in high-risk HIV-infected patients who are intolerant to trimethoprim andor sulfonamides
Both aerosolized pentamidine and dapsone have been shown to prevent PCP but both drugs cause side effects This study attempts to determine which drug is more efficacious as prophylaxis against PCP in patients who cannot tolerate trimethoprimsulfamethoxazole
Both aerosolized pentamidine and dapsone have been shown to prevent PCP but both drugs cause side effects This study attempts to determine which drug is more efficacious as prophylaxis against PCP in patients who cannot tolerate trimethoprimsulfamethoxazole
Detailed Description:
Both aerosolized pentamidine and dapsone have been shown to prevent PCP but both drugs cause side effects This study attempts to determine which drug is more efficacious as prophylaxis against PCP in patients who cannot tolerate trimethoprimsulfamethoxazole
Patients are evenly divided between two treatment arms to receive either aerosolized pentamidine every 4 weeks or dapsone orally three times weekly Follow-up data is collected every 3 months and patients are clinically evaluated every 6 months Patients who develop PCP or a severe or persistent study drug toxicity may be switched to the alternative study drug at the clinicians discretion Average duration of follow-up is 2 years
Patients are evenly divided between two treatment arms to receive either aerosolized pentamidine every 4 weeks or dapsone orally three times weekly Follow-up data is collected every 3 months and patients are clinically evaluated every 6 months Patients who develop PCP or a severe or persistent study drug toxicity may be switched to the alternative study drug at the clinicians discretion Average duration of follow-up is 2 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 |
|---|---|---|---|
| 11565 | REGISTRY | DAIDS ES Registry Number | None |