Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001027
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia PCP in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Trial of Parenteral Pentamidine for PCP Prophylaxis in HIV-Infected Children Who Are Intolerant to Oral Trimethoprim-Sulfamethoxazole
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 pharmacokinetics of biweekly and monthly dose regimens of intravenous pentamidine in HIV-infected infants and children who require PCP prophylaxis and who are intolerant to oral trimethoprim - sulfamethoxazole To determine the safety and tolerance of these regimens in this patient population
Secondary To obtain information on the rate of PCP breakthrough in infants and children receiving parenteral pentamidine prophylaxis
Prophylaxis against Pneumocystis carinii pneumonia is recommended for all HIV-infected children considered to be at high risk In children younger than 5 years of age with intolerance to trimethoprim - sulfamethoxazole parenteral pentamidine may be a successful alternative
Secondary To obtain information on the rate of PCP breakthrough in infants and children receiving parenteral pentamidine prophylaxis
Prophylaxis against Pneumocystis carinii pneumonia is recommended for all HIV-infected children considered to be at high risk In children younger than 5 years of age with intolerance to trimethoprim - sulfamethoxazole parenteral pentamidine may be a successful alternative
Detailed Description:
Prophylaxis against Pneumocystis carinii pneumonia is recommended for all HIV-infected children considered to be at high risk In children younger than 5 years of age with intolerance to trimethoprim - sulfamethoxazole parenteral pentamidine may be a successful alternative
Thirty-two children are randomized to one of two treatment arms Patients receive pentamidine on either a biweekly or a monthly treatment schedule Treatment continues until the last child enrolled has received at least 6 months of pentamidine Patients are stratified according to age 24 months or age 24 months Steady-state pharmacokinetics will be examined in a subsample of 20 patients
Thirty-two children are randomized to one of two treatment arms Patients receive pentamidine on either a biweekly or a monthly treatment schedule Treatment continues until the last child enrolled has received at least 6 months of pentamidine Patients are stratified according to age 24 months or age 24 months Steady-state pharmacokinetics will be examined in a subsample of 20 patients
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 |
|---|---|---|---|
| 11164 | REGISTRY | DAIDS ES Registry Number | None |