Ignite Creation Date:
2024-05-04 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000739
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection
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:
Primary To compare the toxicity of daily versus weekly dapsone in HIV-infected infants and children to study the pharmacokinetics of orally administered dapsone in HIV-infected infants and children
Secondary To obtain information on the rate of Pneumocystis carinii pneumonia PCP breakthrough in children receiving two different dose regimens of dapsone
Prophylaxis for Pneumocystis carinii pneumonia PCP is recommended for all HIV-infected children considered to be at high risk Approximately 15 percent of children are intolerant to trimethoprim sulfamethoxazole the first choice drug for PCP prophylaxis Since many children are also unable to take or tolerate aerosolized pentamidine dapsone is a second choice for PCP prophylaxis The most favorable dose regimen for dapsone has not been established
Secondary To obtain information on the rate of Pneumocystis carinii pneumonia PCP breakthrough in children receiving two different dose regimens of dapsone
Prophylaxis for Pneumocystis carinii pneumonia PCP is recommended for all HIV-infected children considered to be at high risk Approximately 15 percent of children are intolerant to trimethoprim sulfamethoxazole the first choice drug for PCP prophylaxis Since many children are also unable to take or tolerate aerosolized pentamidine dapsone is a second choice for PCP prophylaxis The most favorable dose regimen for dapsone has not been established
Detailed Description:
Prophylaxis for Pneumocystis carinii pneumonia PCP is recommended for all HIV-infected children considered to be at high risk Approximately 15 percent of children are intolerant to trimethoprim sulfamethoxazole the first choice drug for PCP prophylaxis Since many children are also unable to take or tolerate aerosolized pentamidine dapsone is a second choice for PCP prophylaxis The most favorable dose regimen for dapsone has not been established
Ninety-six HIV-infected infants and children who are intolerant to trimethoprim sulfamethoxazole TMP SMX are randomized to receive oral dapsone in a lower dose once daily or at a higher dose once weekly Treatment continues until the last patient enrolled has received at least 3 months of therapy Blood samples are drawn between weeks 4 and 8 at weeks 12 and 24 and every 3 months thereafter during dapsone administration
Ninety-six HIV-infected infants and children who are intolerant to trimethoprim sulfamethoxazole TMP SMX are randomized to receive oral dapsone in a lower dose once daily or at a higher dose once weekly Treatment continues until the last patient enrolled has received at least 3 months of therapy Blood samples are drawn between weeks 4 and 8 at weeks 12 and 24 and every 3 months thereafter during dapsone administration
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 |
|---|---|---|---|
| 11154 | REGISTRY | DAIDS ES Registry Number | None |