Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000773
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
Phase I Safety and Pharmacokinetics Study of Microparticulate Atovaquone m-Atovaquone 566C80 in HIV-Infected and Perinatally Exposed Infants and Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase I Safety and Pharmacokinetics Study of Microparticulate Atovaquone m-Atovaquone 566C80 in HIV-Infected and Perinatally Exposed Infants and Children
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 the safety tolerance and pharmacokinetics of a new improved microparticulate suspension formulation of atovaquone administered at one of two dose levels per 093094 amendment a third dose level was added daily for 12 days in HIV-infected and perinatally exposed per 8995 amendment infants and children who are at risk of developing Pneumocystis carinii pneumonia PCP
Atovaquone has shown prophylactic potential in adults in the treatment of PCP but is poorly absorbed in tablet form To improve the bioavailability of atovaquone a new formulation has been prepared as a microparticulate suspension Since studies in adults have demonstrated substantial safety of this drug evaluation in children is being pursued
Atovaquone has shown prophylactic potential in adults in the treatment of PCP but is poorly absorbed in tablet form To improve the bioavailability of atovaquone a new formulation has been prepared as a microparticulate suspension Since studies in adults have demonstrated substantial safety of this drug evaluation in children is being pursued
Detailed Description:
Atovaquone has shown prophylactic potential in adults in the treatment of PCP but is poorly absorbed in tablet form To improve the bioavailability of atovaquone a new formulation has been prepared as a microparticulate suspension Since studies in adults have demonstrated substantial safety of this drug evaluation in children is being pursued
Three cohorts of four patients each ages 2-12 years 3 months to less than 2 years and 1 month to less than 3 months receive atovaquone daily for 12 days The oldest age group is treated first In the absence of unacceptable toxicity the dose of atovaquone is escalated in subsequent 4-patient cohorts representing each of the age stratifications and per 93094 amendment in a separate 4-patient cohort aged 3 months to less than 2 years If two of four patients in a given cohort experience unacceptable toxicity at the initial dose two additional patients in the same age range are entered Blood samples are drawn for pharmacokinetic evaluation Patients are followed to day 24 Per 93094 amendment patients aged 3 months to less than 2 years of age who received one of the lower doses may re-enroll in the higher dose cohort after a 1-month washout
Three cohorts of four patients each ages 2-12 years 3 months to less than 2 years and 1 month to less than 3 months receive atovaquone daily for 12 days The oldest age group is treated first In the absence of unacceptable toxicity the dose of atovaquone is escalated in subsequent 4-patient cohorts representing each of the age stratifications and per 93094 amendment in a separate 4-patient cohort aged 3 months to less than 2 years If two of four patients in a given cohort experience unacceptable toxicity at the initial dose two additional patients in the same age range are entered Blood samples are drawn for pharmacokinetic evaluation Patients are followed to day 24 Per 93094 amendment patients aged 3 months to less than 2 years of age who received one of the lower doses may re-enroll in the higher dose cohort after a 1-month washout
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 |
|---|---|---|---|
| 11204 | REGISTRY | DAIDS ES Registry Number | None |