Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000816
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
Gradual Initiation of SulfamethoxazoleTrimethoprim as Primary Pneumocystis Carinii Pneumonia Prophylaxis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Gradual Initiation of TrimethoprimSulfamethoxazole as Primary Pneumocystis Carinii Pneumonia Prophylaxis
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 determine whether gradual initiation of sulfamethoxazoletrimethoprim SMXTMP reduces the incidence of treatment-limiting adverse reactions compared to the routine initiation of the drugs for Pneumocystis carinii pneumonia PCP prophylaxis in HIV-infected patients
Although a number of clinical trials have demonstrated the superiority of SMXTMP for PCP prophylaxis the incidence of adverse reactions to this medication is high In a pilot study in which patients were initiated with SMXTMP prophylaxis by gradually increasing the dose over 2 weeks no significant adverse reactions have occurred
Although a number of clinical trials have demonstrated the superiority of SMXTMP for PCP prophylaxis the incidence of adverse reactions to this medication is high In a pilot study in which patients were initiated with SMXTMP prophylaxis by gradually increasing the dose over 2 weeks no significant adverse reactions have occurred
Detailed Description:
Although a number of clinical trials have demonstrated the superiority of SMXTMP for PCP prophylaxis the incidence of adverse reactions to this medication is high In a pilot study in which patients were initiated with SMXTMP prophylaxis by gradually increasing the dose over 2 weeks no significant adverse reactions have occurred
Patients are randomized to receive either gradually increasing doses of SMXTMP suspension or routine daily initiation of SMXTMP double strength DS tablets for 2 weeks All patients will then be switched over to receive open-label SMXTMP DS tablets daily for 10 weeks
Patients are randomized to receive either gradually increasing doses of SMXTMP suspension or routine daily initiation of SMXTMP double strength DS tablets for 2 weeks All patients will then be switched over to receive open-label SMXTMP DS tablets daily for 10 weeks
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 |
|---|---|---|---|
| 11244 | REGISTRY | DAIDS ES Registry Number | None |