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

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Drug: Atazanavir

• Registration Number: NCT00411957
• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

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.

Study Timeline

• Study First Submitted: 2006-12-13
• Study First Submitted QC: 2006-12-14
• Study First Posted: 2006-12-15
• Study Start: 2007-01
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Atazanavir	ATV/r 300/100 mg
2	Atazanavir	ATV/r 200/100 mg OD

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

HIV-NAT, Thai Red Cross AIDS Research Center; 🇹🇭 Bangkok, Thailand