Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000802
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Randomized Comparative Study of Daily Dapsone and Daily Atovaquone for Prophylaxis Against PCP in HIV-Infected Patients Who Are Intolerant of Trimethoprim andor 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 Study of Daily Dapsone and Daily Atovaquone for Prophylaxis Against PCP in HIV-Infected Patients Who Are Intolerant of 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 efficacy and safety of dapsone versus atovaquone in preventing or delaying the onset of histologically proven or probable Pneumocystis carinii pneumonia in HIV-infected patients with CD4 counts 200 cellsmm3 or 15 percent of the total lymphocyte count who are intolerant to trimethoprim andor sulfonamides
Trimethoprimsulfamethoxazole TMPSMX which is effective for secondary PCP prophylaxis is associated with allergic manifestations and side effects that limit its use Patients who are intolerant of TMPSMX require an effective alternative Dapsone and atovaquone have both shown promise as PCP prophylactic agents
Trimethoprimsulfamethoxazole TMPSMX which is effective for secondary PCP prophylaxis is associated with allergic manifestations and side effects that limit its use Patients who are intolerant of TMPSMX require an effective alternative Dapsone and atovaquone have both shown promise as PCP prophylactic agents
Detailed Description:
Trimethoprimsulfamethoxazole TMPSMX which is effective for secondary PCP prophylaxis is associated with allergic manifestations and side effects that limit its use Patients who are intolerant of TMPSMX require an effective alternative Dapsone and atovaquone have both shown promise as PCP prophylactic agents
Patients are randomized to receive either dapsone or atovaquone daily with follow-up at the clinic every 4 months
Patients are randomized to receive either dapsone or atovaquone daily with follow-up at the clinic every 4 months
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 |
|---|---|---|---|
| 11253 | REGISTRY | DAIDS-ES | None |
| CPCRA 034 | None | None | None |