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.
Primary Outcome Measures:
- the pharmacokinetics of atazanavir/ritonavir (ATV/RTV) 200/100 mg once daily in a sample of 22 patients experiencing virological success [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The pharmacokinetic and pharmacodynamic between these patients and data from Thai cohort treated with ATV/RTV 300/100 mg OD [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
- short term safety, tolerability and efficacy data in these PK participating patients [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Enrollment: |
22 |
Study Start Date: |
January 2007 |
Study Completion Date: |
January 2008 |
Primary Completion Date: |
January 2008 (Final data collection date for primary outcome measure) |
1: Active Comparator
ATV/r 300/100 mg
|
Drug: Atazanavir
ATV/r 300/100mg OD vs ATV/r 200/100 mg OD
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2: Active Comparator
ATV/r 200/100 mg OD
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Drug: Atazanavir
ATV/r 300/100mg OD vs ATV/r 200/100 mg OD
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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.