Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000811
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Phase IIIII Double-Blind Two-Armed Study of Micronized Atovaquone and Azithromycin ATAZ as Compared to Trimethoprim-Sulfamethoxazole TMPSMX in the Prevention of Serious Bacterial Infections When Used in Children Aged 3 Months to 19 Years With 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:
This study compares 2 different treatments administered to try to prevent serious bacterial infections such as pneumonia in HIV-positive children A combination of drugs azithromycin plus atovaquone will be compared to sulfamethoxazole-trimethoprim SMXTMP alone This study also evaluates the long-term safety and tolerance of these different drugs
SMXTMP is a commonly prescribed drug for the prevention of bacterial infections However the combination of azithromycin and atovaquone may be safer and more effective than SMXTMP This study compares the 2 treatments
SMXTMP is a commonly prescribed drug for the prevention of bacterial infections However the combination of azithromycin and atovaquone may be safer and more effective than SMXTMP This study compares the 2 treatments
Detailed Description:
Although SMXTMP remains the drug of choice for PCP prophylaxis drug sensitivity may limit its use Atovaquone has demonstrated greater safety than SMXTMP and thus is suitable as a candidate drug for treatment and prophylaxis of PCP Azithromycin with a broad anti-microbial spectrum including mycoplasma and atypical mycoplasma is an attractive prophylactic agent for use in children with HIV infection due to its relative safety and once-daily dosing regimen Therefore the combination of atovaquone and azithromycin may offer broader antimicrobial coverage and greater safety than SMXTMP
Patients are randomized to receive either SMXTMP or combination micronized atovaquoneazithromycin Crossover to the alternative regimen may occur if serious toxicity is observed Patients are monitored for occurrence of serious bacterial infections or PCP breakthrough and when a serious bacterial infection occurs patients are crossed over to the alternative regimen Treatment continues until 2 years after the last patient is enrolled The first 30 patients will undergo a pharmacokinetic profile Patients are followed every 4 weeks for the first 4 months then every 8 weeks thereafter AS PER AMENDMENT 052899 This study was closed to infants and children age 19 months and older on 21599 the study is now open to infants age 3 to 18 months Stage II Patients who are age 24 months or older at the time of Stage I closure will have end-of-study evaluations and will no longer be followed on protocol Patients who are less than 24 months of age at the time of Stage I closure will be allowed to continue in the current version of the protocol Enrollment for children age 3 to 18 months will continue until 50 subjects have been randomized Because Stage II is an unblinded study patients who are less than 24 months of age currently enrolled on Version 40 will have their study medication regimen unblinded and their atovaquone dose increased
Patients are randomized to receive either SMXTMP or combination micronized atovaquoneazithromycin Crossover to the alternative regimen may occur if serious toxicity is observed Patients are monitored for occurrence of serious bacterial infections or PCP breakthrough and when a serious bacterial infection occurs patients are crossed over to the alternative regimen Treatment continues until 2 years after the last patient is enrolled The first 30 patients will undergo a pharmacokinetic profile Patients are followed every 4 weeks for the first 4 months then every 8 weeks thereafter AS PER AMENDMENT 052899 This study was closed to infants and children age 19 months and older on 21599 the study is now open to infants age 3 to 18 months Stage II Patients who are age 24 months or older at the time of Stage I closure will have end-of-study evaluations and will no longer be followed on protocol Patients who are less than 24 months of age at the time of Stage I closure will be allowed to continue in the current version of the protocol Enrollment for children age 3 to 18 months will continue until 50 subjects have been randomized Because Stage II is an unblinded study patients who are less than 24 months of age currently enrolled on Version 40 will have their study medication regimen unblinded and their atovaquone dose increased
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11231 | REGISTRY | DAIDS-ES | None |
| PACTG 254 | None | None | None |