Pharmacokinetic Study of 2 Doses of ATV/r OD + 2 NRTIs in Thai HIV-1 Infected Patients

The Pharmacokinetics of Atazanavir / Ritonavir 200/100 OD Versus 300/100 mg OD in Combination With 2 NRTIs in HIV Pre-treated Patients

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00411957

Enrollment

Registered

2006-12-15

Start date

2007-01-31

Completion date

2008-01-31

Last updated

2020-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

atazanavir/ritonavir, pharmacokinetic of ATV/r200/100 OD+2NRTIs

Brief summary

Several studies from HIV-NAT have demonstrated high nevirapine, indinavir, saquinavir and lopinavir/r 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 ATV/RTV 300/100 OD may be higher than the acceptable range and could be associated with ATV related toxicity.

Detailed description

We are interested in once daily ATV/RTV 200/100 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 atazanavir/ritonavir once daily dose in combination of NRTIs in HIV-1 pretreated patients. We believe that the PK parameters of ATV/RTV given at 200/100mg daily in Thai patients will be equivalent to the ATV/RTV 300/100mg 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 ATV/RTV 200/100 mg OD + 2NRTIs is in acceptable range or comparable with standard dose of ATV/RTV 300/100 mg OD, long term efficacy will be explored later.

Interventions

DRUGAtazanavir

ATV/r 300/100mg OD vs ATV/r 200/100 mg OD

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Written informed consent * Adults HIV patients currently using ATV/RTV 300/100 mg OD plus 2 NRTIs * HIV RNA \< 50 copies/ml

Exclusion criteria

* Inability to understand the nature and extent of the study and the procedures required. * ALT/ AST more than 5x upper limit * Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion. * Use of concomitant medication that may interfere with the pharmacokinetics of atazanavir, and ritonavir * History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study. * Active drug abuse or heavy alcoholic drinking * History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study. * Active drug abuse or heavy alcoholic drinking

Design outcomes

Primary

Measure	Time frame
the pharmacokinetics of atazanavir/ritonavir (ATV/RTV) 200/100 mg once daily in a sample of 22 patients experiencing virological success	1 year

Secondary

Measure	Time frame
The pharmacokinetic and pharmacodynamic between these patients and data from Thai cohort treated with ATV/RTV 300/100 mg OD	4 weeks
short term safety, tolerability and efficacy data in these PK participating patients	4 weeks

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026