Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197639
Status:
COMPLETED
Last Update Posted:
2010-11-15
First Post:
2005-09-13
Brief Title:
Pharmacokinetic Study of Indinavir Drug Levels When Boosted With Ritonavir in Thailand
Sponsor:
Harvard School of Public Health HSPH
Organization:
Harvard School of Public Health HSPH
Study Overview
Official Title:
A Pharmacokinetic Study to Assess the Inter-patient Variability of Indinavir Drug Levels When Boosted With Ritonavir in Thai Patients on Highly Active Antiretroviral Therapy
Status:
COMPLETED
Status Verified Date:
2010-11
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 looks at the ways indinavir drug levels when boosted with ritonavir may vary from patient to patient The study population are HIV Thai individuals
Detailed Description:
This study will assess the inter-individual variability of indinavir drug levels boosted with ritonavir in Thai patients Data will be collected in patients participating in the randomized study Monitoring Highly Active Antiretroviral Therapy HAART in HIV-infected patients in Thailand PHPT-3 HSC 10668 The first 20 patents in PHPT-3 will have steady-state pharmacokinetic sparse sampling performed at pre-dose and 1 25 4 and 12 hours after drug intake 1 and 2 months after initiating IDVr 400100 mg twice daily IDVr plasma concentrations will be determined by high performance liquid chromatography This spare PK data will be pooled with indinavir concentration data collected within an intensive pharmacokinetic studies of IDVr Cressey TR et al 2005 JAC 55 p1041-44 Population means and variances of indinavir and ritonavir pharmacokinetic parameters were estimated using non-linear mixed effects regression models NONMEM Version VI The validity of the final model was evaluated using a visual predictive check VPC and bootstrap re-sampling techniques
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 |
|---|---|---|---|
| R01HD042964 | NIH | None | httpsreporternihgovquickSearchR01HD042964 |