Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411957
Status:
COMPLETED
Last Update Posted:
2020-07-17
First Post:
2006-12-13
Brief Title:
Pharmacokinetic Study of 2 Doses of ATVr OD 2 NRTIs in Thai HIV-1 Infected Patients
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Organization:
The HIV Netherlands Australia Thailand Research Collaboration
Study Overview
Official Title:
The Pharmacokinetics of Atazanavir Ritonavir 200100 OD Versus 300100 mg OD in Combination With 2 NRTIs in HIV Pre-treated Patients
Status:
COMPLETED
Status Verified Date:
2020-07
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:
Several studies from HIV-NAT have demonstrated high nevirapine indinavir saquinavir and lopinavirr levels when compared to Caucasian patients Until now the pharmacokinetics of atazanavir have not been explored in a Thai population We postulate that ATV levels as with other PIs are higher in Thai people Therefore the level of ATV in ATVRTV 300100 OD may be higher than the acceptable range and could be associated with ATV related toxicity
Detailed Description:
We are interested in once daily ATVRTV 200100 mg OD because of the convenience reduction in ATV doses which may improve adherence while reducing toxicity and cost There are limited prospective studies evaluating pharmacokinetic and long term efficacy and safety of atazanavirritonavir once daily dose in combination of NRTIs in HIV-1 pretreated patients We believe that the PK parameters of ATVRTV given at 200100mg daily in Thai patients will be equivalent to the ATVRTV 300100mg once daily dosing in Caucasian patients when combined with 2NRTIs and that the once daily regimen will have better safety tolerability profile and cost saving while maintaining good CD4 and VL outcome If the pharmacokinetic profile of ATVRTV 200100 mg OD 2NRTIs is in acceptable range or comparable with standard dose of ATVRTV 300100 mg OD long term efficacy will be explored later
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